MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 6MM2CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 4400602S

Device Problem Burst Container or Vessel (1074)

Patient Problem Not Applicable (3189)

Event Date 07/13/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17633516 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 Description

As reported, a 80 6 mm x 2 cm powerflex pro was inflated and ruptured at ten atmospheres (10 atm).No patient injury was reported.The lesion was the superficial femoral artery (sfa) with calcification.After the balloon ruptured it was replaced with a same size non-cordis balloon catheter (bc) and inflated at fifteen atmospheres (15 atm) to complete the procedure.The product has been discarded in the hospital and will not be returned for analysis due to the patient having a suspicious infectious disease.

Manufacturer Narrative

The lesion was severely calcified, with 70 percent stenosis, and no tortuosity.The device was not used for a chronic total occlusion (cto).There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.No kinks or other damages were noted prior to inserting the product into the patient.The device prepped normally.The same indeflator was used successfully with other devices.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The balloon catheter was removed easily and intact from the patient.As reported, a 6x20mm 80cm powerflex pro percutaneous transluminal angioplasty (pta) catheter was inflated and ruptured at ten atmospheres (10 atm).It was then replaced with a same size non-cordis balloon catheter (bc) and inflated at fifteen atmospheres (15 atm) to complete the procedure.No patient injury was reported.The lesion was the superficial femoral artery (sfa) with severe calcification, had 70% rate of stenosis, and no tortuosity.The device was not used for a chronic total occlusion (cto).There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.No kinks or other damages were noted prior to inserting the product into the patient.The device prepped normally.The same indeflator was used successfully with other devices.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The catheter was never in an acute bend.After the balloon ruptured, the balloon catheter was removed easily and intact from the patient.Additional procedure details were requested but are unknown.The device was not returned for analysis due to the patient having suspicious infectious disease.A device history record (dhr) review of lot 17633516 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¿ could not be confirmed as the device was not returned for analysis.The exact cause of the burst could not be determined.Based on the limited information available for review, vessel characteristics (severe calcification with 70% stenosis) and procedural/handling factors may have contributed to the reported event since calcified/resistant lesions can cause damage to a balloon.According to the instructions for use, which is not intended as a mitigation, ¿the rated burst pressure is based on the result of in vitro testing.At least 99.9% of the balloons (with a 95% confidence level) will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over pressurization.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.¿ neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective/preventive action will be taken at this time.

• Brand Name: POWERFLEXPRO 6MM2CM 80
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7769837
• MDR Text Key: 117158969
• Report Number: 9616099-2018-02303
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K112797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 4400602S
• Device Lot Number: 17633516
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALLOON CATHETER MUSTANG, BOSTON SCIENTIFIC