MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 6MM22CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4400622X

Device Problem Burst Container or Vessel (1074)

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

Event Date 06/15/2022

Event Type  malfunction  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.This device is available for analysis but has not yet been received.

Event Description

As reported, the powerflex pro 6mm 22cm balloon was ruptured.There was no reported injury to the patient.The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b4, g3, h1, h2, h3 and h6.As reported, the powerflex pro 6mm 22cm balloon was ruptured below the rbp while in the left iliac artery.The device was removed intact from the patient.The case was completed with the use of a new powerflex pro.There was no reported injury to the patient.The balloon was confirmed that it ruptured below rbp while in the vessel.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop, removing the protective balloon cover, stylet, or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.The device was prepped per the ifu and was able to maintain negative pressure.The lesion was noted to have moderate calcification with little to no to tortuosity and had a stenosis of 75%.The device was not being used to treat a chronic total occlusion (cto).The non-cordis inflation device was filled with a saline/contrast ratio of 50/50.The same inflation device was used successfully with other devices during procedure.The balloon catheter did not have any resistance/friction during insertion into the rotating hemostatic valve.There was no resistance/friction while inserting the balloon through the guide catheter.The device was advanced through the vessel without difficulty.There was no difficulty crossing the lesion.The catheter was never in an acute bend and was never kinked during use.The device was returned for analysis.A non-sterile powerflex pro 6mm x 22cm 135 unit was received for analysis inside a plastic bag.Per visual analysis, neither burst, rupture nor any damage that could cause the reported failure was observed.Per functional analysis, a lab sample inflator/deflator device partially filled with water was attached to the inflation lumen of the unit and positive pressure was applied.The balloon was inflated and deflated as expected.With no anomalies found.Therefore, balloon inflation testing was successfully performed.Next, guidewire insertion/withdrawal testing was attempted; however, resistance was experienced between the guidewire lumen of the unit and the appropriate.035¿ emerald guidewire lab sample.Guidewire resistance was felt at 3.5cm from the proximal seal when gw insertion was performed via the proximal area, and at 10cm from the tip when gw insertion was performed via the distal area.The device failed insertion/withdrawal testing with an unsuccessful result.Per microscopic analysis, the guidewire tubing was exposed from the proximal seal to the tip area to thoroughly inspect the tubing profile, with a particular focus on the identified resistance areas between 3.5cm from the proximal seal and 10cm from the tip, where the resistance felt.The unit was inspected under the vision system and a compressed-like condition was observed on the unit between the previously identified areas where resistance was met.The compressed-like condition was easily observed when the inner guidewire tubing was rotated approximately 90 degrees to observe the inner guidewire tubing profile.Per dimensional analysis, a measurement was performed to verify if the unit presented an oval shape that has been identified in previous complaint units returned for analysis under guidewire lumen-obstructed malfunction code.The unit was cut at the previous identified areas of interest to verify the correct inner diameter throughout the guidewire lumen of the unit on the balloon section, including the zone where the resistance was experienced.Currently, there is no specification for the id of the guidewire lumen.However, the drawing specification was used for its comparison against the measurements taken.Results failed at the areas where the gw resistance was felt.Per dimensional analysis, the diameter of the guidewire lumen was found to be out of specification (measurement result was.030¿) in the areas where the resistance was felt.Resistance and oval shape in the guidewire lumen were confirmed at the balloon section.A product history record (phr) review of lot 82218356 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst - at/below rbp¿ was not confirmed via device analysis as no anomalies were noted to the balloon, the device passed inflation and deflation testing.Subsequently a secondary failure of ¿guidewire lumen resistance/friction¿ was confirmed via device analysis during insertion/withdrawal testing.However, the exact cause could not be determined.Several factors are being considered and further investigation is required to find a definitive root cause.Therefore, based on the information available for review, it is difficult to draw a clinical conclusion between the device and the events reported as the balloon performed as intended and no ruptures were noted to the balloon material.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 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.¿ the product analysis suggests that the incidental secondary finding noted during analysis may be associated to the manufacturing process.Therefore, a risk assessment has been initiated for further investigation.

Event Description

As reported, the powerflex pro 6mm 22cm balloon was ruptured below the rbp while in the left iliac artery.The device was removed intact from the patient.The case was completed with the use of a new powerflex pro.There was no reported injury to the patient.The balloon was confirmed that it ruptured below rbp while in the vessel.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop, removing the protective balloon cover, stylet, or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.The device was prepped per the ifu and was able to maintain negative pressure.The lesion was noted to have moderate calcification with little to no to tortuosity.The lesion had a stenosis of 75%.The device was not being used to treat a chronic total occlusion (cto).The non-cordis inflation device was filled with a saline/contrast ratio of 50/50.The same inflation device was used successfully with other devices during procedure.The balloon catheter did not have any resistance/friction during insertion into the rotating hemostatic valve.There was no resistance/friction while inserting the balloon through the guide catheter.The device was advanced through the vessel without difficulty.There was no difficulty crossing the lesion.The catheter was never in an acute bend and was never kinked during use.The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: a2.A3, b4, d4, d9, g3, h1, h2, h3 and h6.A review of the manufacturing documentation associated with lot 82218356 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, the powerflex pro 6mm 22cm balloon was ruptured below the rbp while in the left iliac artery.The device was removed intact from the patient.The case was completed with the use of a new powerflex pro.There was no reported injury to the patient.The balloon was confirmed that it ruptured below rbp while in the vessel.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop, removing the protective balloon cover, stylet, or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.The device was prepped per the ifu and was able to maintain negative pressure.The lesion was noted to have moderate calcification with little to no to tortuosity.The lesion had a stenosis of 75%.The device was not being used to treat a chronic total occlusion (cto).The non-cordis inflation device was filled with a saline/contrast ratio of 50/50.The same inflation device was used successfully with other devices during procedure.The balloon catheter did not have any resistance/friction during insertion into the rotating hemostatic valve.There was no resistance/friction while inserting the balloon through the guide catheter.The device was advanced through the vessel without difficulty.There was no difficulty crossing the lesion.The catheter was never in an acute bend and was never kinked during use.The device will be returned for evaluation.

• Brand Name: POWERFLEXPRO 6MM22CM 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; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14948363
• MDR Text Key: 300791007
• Report Number: 9616099-2022-05781
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032059647
• UDI-Public: (01)20705032059647(17)240331(10)82218356
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K112797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 4400622X
• Device Catalogue Number: 4400622X
• Device Lot Number: 82218356
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2022
• Initial Date FDA Received: 07/07/2022
• Supplement Dates Manufacturer Received: 07/14/2022; 08/17/2022
• Supplement Dates FDA Received: 08/09/2022; 08/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2021
• 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
• Patient Age: 72 YR
• Patient Sex: Male