MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 8MM6CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4400806S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A non-sterile unit of a powerflexpro 8mm 6cm 80 was received for analysis coiled inside a plastic bag.Per visual analysis, the balloon looks like it¿s been previously inflated.The unit was thoroughly inspected at naked eye and no other anomalies were observed.Balloon inflation was performed.A lab inflator/deflator device was attached to the inflation lumen of unit and pressure applied.A burst was observed on the balloon¿s proximal area.Per sem analysis on the balloon leakage observed during inflation test, results showed that the balloon burst was caused by a rupture on the balloon surface.The inner surface presented no anomalies near to the balloon rupture.The outer surface presented evidence of scratch marks near to the balloon rupture.This type of damage is commonly caused during the interaction of the balloon material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the balloon outer surface could probably led to the rupture condition found on the received balloon.It seems the balloon material near the rupture was torn with a sharp object from the outside of the balloon.No other anomalies were observed during the sem analysis.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the 8mm x 6cm 80 powerflex pro balloon catheter (bc) was found that it could not be filled normally after it was open from packaging.There was no reported patient injury.During product evaluation, the balloon leakage was observed during inflation test, results showed that the balloon burst was caused by a rupture on the balloon surface.
Additional Manufacturer Narrative
Complaint conclusion: the 8mm x 6cm 80 powerflex pro balloon catheter (bc) was found that it could not be filled normally after it was opened from the packaging.There was no reported patient injury.Additional procedural details were requested but are unknown.One product was returned for analysis.A non-sterile powerflex pro 8mm x 6cm 80 was received for analysis coiled inside a plastic bag.Per visual analysis, the balloon appears to have been previously inflated.The unit was thoroughly inspected at naked eye and no other anomalies were observed.Functional analysis was performed.A lab inflator/deflator device was attached to the inflation lumen of unit and pressure applied.A burst was observed on the balloon¿s proximal area.Per sem analysis, results revealed that the balloon burst was caused by a rupture on the balloon surface.The inner surface presented no anomalies, the outer surface presented evidence of scratch marks adjacent to the balloon rupture.This type of damage is commonly caused during the interaction of the balloon material with a sharp object or mechanical damage.It seems the balloon material near the rupture was torn with a sharp object from the outside of the balloon.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82162521 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon - inflation difficulty¿ and "balloon - burst" were confirmed since the balloon would not inflate due to the balloon burst noted during inflation testing.Based on the information available for review, vessel characteristics although unknown, may have contributed to the reported event.Analysis revealed scratch marks adjacent to the balloon rupture on the outer surface of the balloon.It appears the balloon material near the rupture was torn with a sharp object from the outside of the balloon.According to the safety information in the instructions for use ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding.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 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.

• Brand Name: POWERFLEXPRO 8MM6CM 80
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 9845099
• Report Number: 9616099-2020-03574
• Device Sequence Number: 742748
• Product Code: LIT
• UDI-Device Identifier: 20705032059838
• UDI-Public: 20705032059838
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K112797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 4400806S
• Device Catalogue Number: 4400806S
• Device Lot Number: 82162521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 03/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 56