MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 8MM8CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4400808X

Device Problems Material Frayed (1262); Material Split, Cut or Torn (4008)

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

Event Date 11/16/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.It is unknown if the device will be returned for testing and evaluation.   additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, after the powerflex pro 8mm8cm 135 balloon catheter was removed from the packaging, it was found that the delivery system at the head-end of the balloon was seriously kinked and split but not yet separated.There was no reported patient injury.The intended procedure was a limb artery balloon angioplasty.The lesion was moderately calcified.There was no vessel tortuosity.The percentage of stenosis was 70%.The device was used for a chronic total occlusion (total occlusion >3 months).The product was received in this condition.The product was stored properly according to the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the product from the packaging.There was no damage noted to the box, pouch or hoop.The procedure was completed with another unknown balloon.The product is expected to be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: as reported, after the powerflex pro 8mm x 8cm 135 balloon catheter was removed from the packaging, it was found that the delivery system at the head-end of the balloon was seriously kinked and split but not yet separated.There was no reported patient injury.The intended procedure was a limb artery balloon angioplasty.The lesion was moderately calcified with 70% stenosis and was used for a chronic total occlusion (total occlusion >3 months).There was no vessel tortuosity.The product was received in this condition.The product was stored properly according to the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the product from the packaging.There was no damage noted to the box, pouch, or hoop.The procedure was completed with another unknown balloon.The product was returned for analysis.A non-sterile powerflex pro 8mm x 8cm 135 percutaneous transluminal angioplasty (pta) balloon catheter was received for analysis inside a clear plastic bag.Per visual analysis, the distal tip of the powerflex pro was thoroughly inspected, and no anomalies could be seen.Neither distal tip- kinked/bent nor frayed/split/torn was found.Besides visual inspection, functional analysis was performed.Inflation/deflation testing was successfully performed on the unit.A lab sample inflator/deflator device partially filled with water was attached to the inflation lumen of the unit, positive pressure was applied.The balloon of the unit was successfully inflated as expected.No anomaly was noted.A product history record (phr) review of lot 82200845 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿distal tip kinked/bent - during prep¿ and ¿distal tip frayed/split/torn - during prep¿ were not confirmed through analysis of the returned device.The exact cause of the reported event could not be determined.It is likely procedural factors and handling of the device, contributed to the event reported by the customer.Per visual analysis and thorough inspection, no anomalies were seen on the distal tip.Next, functional analysis was performed, the balloon inflated without difficulty and no burst/leaks/kinks/tears were noted to the balloon or the distal tip of the device.Therefore, based on the information available for review, it is difficult to draw a clinical conclusion between the device and the event reported by the customer as no anomalies were noted on the device.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.Proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.Always verify integrity of the catheter after removal.¿ 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.

Manufacturer Narrative

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.

• Brand Name: POWERFLEXPRO 8MM8CM 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: 13017900
• MDR Text Key: 285842623
• Report Number: 9616099-2021-05199
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032059869
• UDI-Public: (01)20705032059869(17)230831(10)82200845
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 4400808X
• Device Catalogue Number: 4400808X
• Device Lot Number: 82200845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2020
• 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: UNK BALLOON