MAUDE Adverse Event Report: CORDIS US. CORP POWERFLEX PRO; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	4400704S
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82265995 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the 7mm x 4cm powerflex pro was unable to retract after deflation from the 5f non-cordis long sheath.The product was removed intact from the patient.There was no reported injury to the patient.The device was stored in the cath lab.The device was stored according to the instructions for use.There was no difficulty removing the product from the hoop, removing the protective balloon cover.There were no kinks or other damages noted prior to inserting the product into the patient.The device was prepped per the ifu.The intended procedure was a pta of the common iliac artery.The lesion was noted to have moderate calcification and the vessel had a little tortuosity.The lesion was noted to have a stenosis of 70%.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion with the device.The catheter was never in an acute bend.The device was only inflated or deflated once prior to removing.The balloon deflated as intended.The saline/contrast ratio and the inflation device was 1:1.The devices will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b5, d9, g3, h1, h2, h3 and h6.
Event or Problem Description
As reported, the 7mm x 4cm powerflex pro was unable to retract after deflation from the 5f non-cordis long sheath.The product was removed intact from the patient.There was no reported injury to the patient.The device was stored in the cath lab.The device was stored according to the instructions for use.There was no difficulty removing the product from the hoop, removing the protective balloon cover.There were no kinks or other damages noted prior to inserting the product into the patient.The device was prepped per the ifu.The intended procedure was a pta of the common iliac artery.The lesion was noted to have moderate calcification and the vessel had a little tortuosity.The lesion was noted to have a stenosis of 70%.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion with the device.The catheter was never in an acute bend.The device was only inflated or deflated once prior to removing.The balloon deflated as intended.The saline/contrast ratio and the inflation device was 1:1.The devices will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b5, g3, g6, h1, h2, h3, h6, and h11.As reported, the 7mm x 4cm powerflex pro was unable to retract after deflation from the 5f non-cordis long sheath.The product was removed intact from the patient.There was no reported injury to the patient.The intended procedure was a pta of the common iliac artery.The lesion was noted to have moderate calcification and the vessel had a little tortuosity.The lesion was noted to have a stenosis of 70%.The device was stored in the cath lab, according to the instructions for use.There was no difficulty removing the product from the hoop or removing the protective balloon cover.There were no kinks or other damages noted prior to inserting the product into the patient.The device was prepped per the ifu.There was no difficulty advancing the balloon catheter through the vessel and no difficulty crossing the lesion with the device.The catheter was never in an acute bend.The device was only inflated/deflated once prior to removing.The balloon deflated as intended.The saline/contrast ratio in the inflation device was 1:1.The device was returned for analysis.A non-sterile ¿powerflexpro 7mm4cm 80¿ was received coiled inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.The unit was thoroughly inspected observing that it does not present any damages or anomalies.The device was received with the balloon deflated and with a non-cordis csi.A dimensional analysis was executed to measure the od of the proximal balloon seal, during this analysis no dimensional issue was observed.Additionally, a non-cordis csi was used for the insertion of the device and was returned with the complaint device.However, this non-cordis csi is not under cordis controls; therefore, cannot be properly examined with the complaint device.The handling of the cordis balloon catheter with the non-cordis concomitant device could be a possible attributable cause to the reported event.A product history record (phr) review of lot 82265995 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.A dimensional analysis was performed to verify the correct od of the proximal balloon seal and was found within specification.The exact cause cannot be determined.The csi returned with the device cannot be analyzed for compatibility as this is a non-cordis device and is not under cordis controls.This device should have been returned to the device manufacturer for further analysis.Therefore, based on the information available for review, it is difficult to draw a clinical conclusion between the devices and the event reported.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.
Event or Problem Description
As reported, the 7mm x 4cm powerflex pro was unable to retract after deflation from the 5f non-cordis long sheath.The product was removed intact from the patient.There was no reported injury to the patient.The device was stored in the cath lab.The device was stored according to the instructions for use.There was no difficulty removing the product from the hoop, removing the protective balloon cover.There were no kinks or other damages noted prior to inserting the product into the patient.The device was prepped per the ifu.The intended procedure was a pta of the common iliac artery.The lesion was noted to have moderate calcification and the vessel had a little tortuosity.The lesion was noted to have a stenosis of 70%.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion with the device.The catheter was never in an acute bend.The device was only inflated or deflated once prior to removing.The balloon deflated as intended.The saline/contrast ratio and the inflation device was 1:1.The devices will be returned for evaluation.

• Brand Name: POWERFLEX PRO
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue nw 60 avenue; miami lakes 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; coyol free zone, building b25, , , costa rica; el coyol alajuela bld 25 ; 7863138372
• MDR Report Key: 18344241
• Report Number: 3007635982-2023-00347
• Device Sequence Number: 20388932
• Product Code: LIT
• UDI-Device Identifier: 20705032059692
• UDI-Public: (01)20705032059692(17)251031(10)82265995
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2024

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 Expiration Date: 10/31/2025
• Device Catalogue Number: 4400704S
• Device Lot Number: 82265995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/22/2023; 03/01/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 01/17/2024; 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5F.-LONG SHEATH; 7MM X 4CM ARROW SHEATH; POWERFLEX PRO
• Patient Sex: Unknown