MAUDE Adverse Event Report: CORDIS CASHEL POWERFLEX P3 F5 4X4 40; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4204040T

Device Problems Burst Container or Vessel (1074); Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2018

Event Type  malfunction  

Manufacturer Narrative

A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.This device was received for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

During a fistulagram in the thigh, it was reported that the power flex p3 balloon catheter (bc) would not inflate because the balloon was breaking as it got caught on part of the catheter graft.There was no patient injury.The patient had a herograft and there was a narrowing were they connected.There was an attempt to balloon the narrowing and the balloon would inflate for a short time and then break.The physician believes that the materials of the graft was shredding the balloons.Only one will be returned for analysis.

Manufacturer Narrative

This is one of two products involved with the reported event.The manufacturing reference number for this event is case (b)(4).The manufacturing reference number for the other complaint is case (b)(4).It was reported that the power flex p3 f5 4x4 40 balloon ruptured.During a fistulagram in the thigh, it was reported that the power flex p3 balloon catheter (bc) would not inflate because the balloon was breaking (the balloon perforated) as it got caught on part of the catheter graft.There was no patient injury.The patient had a herograft and there was a narrowing at the anastamosis.There was an attempt to balloon the narrowing and the balloon would inflate for a short time and then break.The physician believes that the materials of the graft was shredding the balloons.There was no difficulty inflating the balloon during prep.The balloon initially inflated normally.There were no difficulties removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product the product into the patient.Contrast media used was the isovue 370- bracco.The contrast to saline ratio was 50/50.The type and brand of inflation device used was abbott; which was successfully used with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve, the guide catheter, or advancing through the vessel.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The product was removed intact (in one piece) from the patient.Only one will be returned for analysis.No other information was provided.A non-sterile powerflex p3 f5 4x4 40 catheter was received coiled for analysis inside a plastic bag.Per visual analysis, the balloon seemed to have been previously inflated /deflated.No other anomalies observed.A device history record (dhr) review of lot 17477977 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Per dp 12169733 rev 2; leak test was performed.Water was applied to the catheter and a leakage was observed in the proximal section of the balloon.A rupture was observed on balloon at 3.5 cm from distal end.Sem analysis results showed that the external surface of balloon presented evidence of scratched and abrasions marks near to the balloon axial burst condition and it is very likely that the same factors that caused the scratched marks on the balloon outer surface can also contribute to the axial burst condition found on the received balloon.The internal surface of the balloon did not present any evidence of damages.The event reported by the customer as ¿balloon- burst ¿was confirmed due to the rupture condition of the unit as received.However, the exact cause of the burst/ rupture condition of the balloon could not be conclusively determined during the analysis.Neither the phr review, nor the product or the sem analysis results suggest that the failure is related to the manufacturing process.The reported ¿balloon burst (peripheral)¿ was confirmed through analysis of the returned device.The exact cause of the burst could not be determined during analysis.Based on the information available for review, vessel characteristics graft anastomosis may have contributed to the burst as evidenced by abrasions noted on the outer surface during analysis.Per the instructions for use (ifu), which is not intended as a mitigation, per the instructions for use ¿balloon pressure should not exceed the rated burst pressure.The rated burst pressure is based on the results of in-vitro testing.At least 99.9% of the balloons (with a 95% confidence), will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over pressurization.Use only the recommended balloon inflation medium.Never use air or any gaseous medium to inflate the balloon.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 review, nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: POWERFLEX P3 F5 4X4 40
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary ; EI
• MDR Report Key: 7298965
• MDR Text Key: 101255795
• Report Number: 9616099-2018-01943
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032004098
• UDI-Public: 20705032004098
• Combination Product (y/n): N
• PMA/PMN Number: K032737
• 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: 04/04/2018

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: Nurse
• Device Expiration Date: 03/31/2019
• Device Model Number: 4204040T
• Device Catalogue Number: 4204040T
• Device Lot Number: 17477977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Distributor Facility Aware Date: 01/29/2018
• Initial Date Manufacturer Received: 01/29/2018
• Initial Date FDA Received: 02/27/2018
• Supplement Dates Manufacturer Received: 01/29/2018
• Supplement Dates FDA Received: 04/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HERO GRAFT CATHETERN
• Patient Age: 64 YR
• Patient Weight: 91