MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 3MM15CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4400315X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the 3mm x 15cm 135cm powerflex balloon did not inflate at the time of the surgery, which means that it was punctured.There was no reported injury to the patient.The product was returned for analysis.A non-sterile powerflex pro 3mm x 15cm 135 balloon catheter was received for analysis inside a plastic bag.Per visual analysis, no physical characteristics could be observed at the naked eye.Functional testing was performed on the unit.A syringe filled with water was attached to the inflation lumen and pressure was applied, leakage was confirmed.Balloon leakage was observed on the proximal and on the distal area of the balloon.Per microscopic analysis, sem analysis showed that the balloon leakages were caused by a rupture on the balloon¿s surface.The inner surface presented no anomalies near the balloon rupture.The outer surface presented evidence of scratch marks near 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 have led to the ruptured 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 82185541 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ was confirmed via device analysis.However, the exact cause cannot be determined.A leakage was confirmed through analysis of the returned device as a rupture was noted on the proximal and distal areas of the balloon.The outer surface of the balloon presented evidence of scratch marks adjacent to the ruptures noted.It is likely vessel characteristics and procedural factors, 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.
Event or Problem Description
As reported, the 3mm 15cm 135cm powerflex balloon did not inflate at the time of the surgery, which means that it was punctured.There was no reported injury to the patient.The device will be returned for evaluation.Per the product evaluation, rupture/burst of the balloon was confirmed.

• Brand Name: POWERFLEXPRO 3MM15CM 135
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12745245
• Report Number: 9616099-2021-05037
• Device Sequence Number: 14572772
• Product Code: LIT
• UDI-Device Identifier: 20705032059098
• UDI-Public: (01)20705032059098(17)230131(10)82185541
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/03/2021

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: 01/31/2023
• Device Model Number: 4400315X
• Device Catalogue Number: 4400315X
• Device Lot Number: 82185541
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 11/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.