MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO POWERFLEXPRO 6MM4CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4400604X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned for evaluation, but the manufacture report is not yet available.Additional information is pending and will be sent in upon 30 days after receipt.
Event or Problem Description
As reported, during the percutaneous transluminal angioplasty (pta) procedure, the 6mm x4cm x 135cm powerflex pro pta balloon catheter (bc) was inflated with normal air pressure, but the balloon burst and could not be used.There was no reported patient injury.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
The device has been returned for evaluation, but the manufacture report is not yet available.A review of the device history record (dhr) associated with lot 82173523 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.Additional information is pending and will be sent in upon 30 days after receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6,h2,h3 and h6 have been updated accordingly.As reported, during the percutaneous transluminal angioplasty (pta) procedure, the 6mm x4cm x 135cm powerflex pro pta balloon catheter (bc) was inflated with normal air pressure, but the balloon burst and could not be used.There was no reported patient injury.Additional information was requested but was reported to be unknown.The product was returned for analysis.A non-sterile powerflex pro 6mm x 4cm 135 percutaneous transluminal angioplasty (pta) balloon catheter involved in the complaint was received for analysis coiled inside a plastic bag.Per visual analysis, the balloon of the unit was observed ruptured/ separated.No other physical characteristics could be observed at the naked eye.Er microscopic analysis, sem analysis was performed to the received balloon unit to identify the possible root cause of the rupture condition on the balloon with the following results: 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 device.It seems the balloon material near the rupture was torn either due to the interaction of the balloon with calcified spicules located on the lesion or 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 82173523 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¿ was confirmed via device analysis.A leakage was confirmed through analysis of the returned device as a rupture was noted on the balloon surface.The outer surface of the balloon presented evidence of scratch marks adjacent to the balloon rupture.It is likely vessel characteristics, although unknown, contributed to the reported event as evidenced by device analysis.The balloon material near the rupture, appears to have been torn either due to the interaction of the balloon with calcified spicules located on the lesion or 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 6MM4CM 135
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• MDR Report Key: 11841809
• Report Number: 9616099-2021-04562
• Device Sequence Number: 19748129
• Product Code: LIT
• UDI-Device Identifier: 20705032059524
• UDI-Public: 20705032059524
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K112797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/07/2021

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: 06/30/2022
• Device Model Number: 4400604X
• Device Catalogue Number: 4400604X
• Device Lot Number: 82173523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 05/21/2021; 06/23/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 06/15/2021; 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1