MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 6MM15CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4400615X

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2022

Event Type  malfunction  

Event Description

As reported, a powerflex pro 6mmx15cm 135 cm percutaneous transluminal angioplasty (pta) balloon catheter became stuck in a 6f 10 cm rain sheath.The sheath and the balloon had to be removed and a new unknown sheath was placed.The balloon catheter was not easily removed from the vessel.There was no reported patient injury.The balloon was pulled ¿negative¿ prior and during the process of trying to remove the balloon from the sheath.The balloon was used to perform a percutaneous transluminal angioplasty (pta) in the superficial femoral artery (sfa) and popliteal arteries.There was no difficulty removing the product from the hoop, protective balloon cover or removing the stylet or any of the sterile packaging components.The device was stored and prepped as per the instructions for use (ifu).There were no kinks or other damages noted prior to inserting the product the product into the patient.The device prepped normally.Eight atm (atmospheres) was the maximum inflation pressure.The balloon had maintained pressure during inflation.The balloon deflated normally and was completely deflated before trying to remove it.The balloon catheter did not kink while being used.The product was intact when removed from the patient.There was no resistance or friction with any other device with the sheath.The user was trained to the sheath.Adequate flush was maintained on the sheath throughout the procedure.The devices were stored per labeling and opened in a sterile field.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The devices will be returned for evaluation.

Manufacturer Narrative

The product history review is expected but has not been completed.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3, h6, and h10.A review of the manufacturing documentation associated with lot 82238458 presented no issues during the manufacturing process that can be related to the reported event.This device has been analyzed but the final, approved draft of the engineering report and its conclusion is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: d8, d9, g3, g6, h1, h2, h3, h6, and h10 as reported, a powerflex pro 6mmx15cm 135 cm percutaneous transluminal angioplasty (pta) balloon catheter became stuck in a 6f 10 cm rain sheath.The sheath and the balloon had to be removed and a new unknown sheath was placed.The balloon catheter was not easily removed from the vessel.There was no reported patient injury.The balloon was pulled ¿negative¿ prior and during the process of trying to remove the balloon from the sheath.The balloon was used to perform a percutaneous transluminal angioplasty (pta) in the superficial femoral artery (sfa) and popliteal arteries.There was no difficulty removing the product from the hoop, protective balloon cover or removing the stylet or any of the sterile packaging components.The device was stored and prepped as per the instructions for use (ifu).There were no kinks or other damages noted prior to inserting the product the product into the patient.The device prepped normally.Eight atm (atmospheres) was the maximum inflation pressure.The balloon had maintained pressure during inflation.The balloon deflated normally and was completely deflated before trying to remove it.The balloon catheter did not kink while being used.The product was intact when removed from the patient.There was no resistance or friction with any other device with the sheath.The user was trained to the sheath.Adequate flush was maintained on the sheath throughout the procedure.The devices were stored per labeling and opened in a sterile field.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.2022-00188970-1 the device was returned for analysis.A non-sterile powerflex pro 6mm15cm 135 was received coiled inside of a plastic bag, along with an f6 cordis sheath introducer.Products were unpacked to proceed with the evaluation.The pta was partially inserted inside the csi.The device was then withdrawn from the csi to be inspected observing that the unit does not present any damages or anomalies.A dimensional analysis was performed to verify the correct od of the proximal balloon seal.Dimensional analysis result was found within specification.Functional analysis was performed to determine if any anomalies is observed during the guidewire insertion/withdrawal testing.The guidewire lumen of the balloon catheter was flushed with water prior to the evaluation.A syringe filled with water was attached to the flushing port and positive pressure was applied until the water flowed out of the wire lumen by the distal tip.Neither resistance nor loose material was observed during the flushing procedure.A lab sample guidewire of the appropriate size was inserted into the guidewire lumen of the balloon catheter through the distal tip.After this the guidewire was withdrawn from the balloon catheter.No resistance, friction or obstruction between the guidewire and the guidewire lumen of the balloon catheter during insertion/withdrawal test was noticed.The returned pta with the lab sample guidewire inside were inserted as a single unit into the cannula of a proper csi french 5 by the cap.However, the balloon got stuck due to it was previously handled and it does not have the pleating.The loss of the original pleated on the balloon cause that it cannot travel inside the sheath of the f5 csi.Additionally, the returned pta was intended to insert in the returned f6 cordis sheath.However, the balloon got stuck due to it was previously handled and it does not have the pleating.The loss of the original pleated on the balloon cause that it cannot travel inside the sheath of the returned f6 csi.A product history record (phr) review of lot 82202691 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.2022-00188970-2 a non- sterile csi ¿6f10cm sw radial" was received inside a clear plastic bag along with one powerflex product.The device was unpacked to proceed with the product evaluation.The csi was thoroughly inspected observing an accordioned condition on the cannula located approximately at 9.5 cm from the distal tip.No other damages or anomalies were observed on the returned product.Functional analysis was performed to determine if any mal function can be found at the returned unit.The catheter sheath introducer was flushed with water prior to the evaluation.A syringe was attached (filled with water) to the csi and the water flowed through the parts and got out at the distal tip as expected, neither resistance to the water flow nor loose material was observed during the flushing procedure.One lab sample vessel dilator with a lab sample guidewire inside was inserted as a single unit into the cannula of the csi by the cap.Then was withdrawn completely from the csi.Despite the accordioned condition neither resistance nor obstruction was felt during the insertion/withdrawn test.Additionally, the returned pta was intended to insert in the returned ¿6f10cm sw radial".However, the balloon got stuck due to it was previously handled and it does not have the pleating.The loss of the original pleated on the balloon cause that it cannot travel inside the sheath of the returned ¿6f10cm sw radial".The test of presence of hydrophilic coating was performed, the unit was immersed in the chemical compound "red conga" observing red zones indicating the presence of a hydrophilic coating.A product history record (phr) review of lot 18094343 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿pta/ptca system withdrawal difficulty- through guide/sheath¿ was not confirmed during analysis of the returned device as received.A dimensional analysis was performed to verify the correct od of the proximal balloon seal and was found within specification.Additionally, the loss of the original pleat on the balloon was noted; therefore, it cannot travel inside the sheath of the returned 6f csi and proper assessment of a withdrawal difficulty cannot be performed.Multiple inflations of the balloon during treatment can affect the return of the balloon pleats to their original profile.The catheter sheath introducer returned with the balloon was also noted to be accordioned.It is assumed these findings along with the interactions between the concomitant devices may have contributed to the failures reported as evidenced by device analysis.The reported ¿pta/ptca system withdrawal difficulty - from vessel¿ could not be properly evaluated due to the nature of the complaint as this cannot be replicated in the lab.Handling and procedural factors that are not limited to, patient¿s anatomy, lesion¿s severity in calcification, stenosis and/or tortuosity.According to the safety information in the instructions for use ¿prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Flush the ¿thru¿ lumen with sterile heparinized saline or a similar isotonic solution.Place the prepared catheter over a prepositioned guidewire and advance the tip to the introduction site.If resistance is met during manipulation, determine the cause of the resistance before proceeding.Consider the use of systemic heparinization.Flush all devices entering the vascular system with sterile heparinized saline or similar isotonic solution.If resistance is met during manipulation, determine the cause of the resistance before proceeding.If strong resistance is met during advancement or withdrawal of the catheter, discontinue movement and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the entire system.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.The event reported by the customer as ¿catheter sheath introducer (csi) ¿ resistance/friction-inner lumen - in patient¿ was not confirmed; however, a secondary failure of an accordioned condition was noted on the cannula during analysis.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿inspect the system contents for any signs of damage; do not use if any damage is present.Soak the csi in sterile heparinized saline or similar isotonic solution to activate the hydrophilic coating.To prevent damage to the csi tip or kinking of the csi body, do not withdraw the vessel dilator while advancing and positioning the csi in the vessel.¿ based on the information available and the phr review, there is no indication that the event is related to the manufacturing process of the unit however, an investigation was previously opened to address the accordioned condition.

• Brand Name: POWERFLEXPRO 6MM15CM 135
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; juarez FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15007965
• MDR Text Key: 297737314
• Report Number: 9616099-2022-05805
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032059623
• UDI-Public: 20705032059623
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4400615X
• Device Catalogue Number: 4400615X
• Device Lot Number: 82238458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN SHEATH
• Patient Sex: Female