MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 10MM4CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4401004X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: as reported, the balloon of a 10mm x 4cm x 135 powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter did not inflate when the physician went to inflate it.There was no reported patient injury.The product was returned for analysis.A non-sterile powerflex pro 10mm x 4cm 135 percutaneous transluminal angioplasty (pta) was received for analysis inside a plastic bag.Per visual analysis, no anomalies were observed by the naked eye.Per functional analysis, a lab sample inflator/deflator device partially filled with water was attached to the inflation lumen of the unit and pressure was applied.A balloon leakage was observed coming from a rupture in the middle section of the balloon.No other anomalies were observed.Per sem analysis, results showed that the leakage on the balloon of the powerflex pro 10mm x 4cm 135 device presented evidence of a ruptured condition and scratch marks near the damaged area on the balloon.This type of damage is commonly caused during the interaction of the 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 could probably led to the damaged condition found on the received device.It seems the material near the damage was ruptured with a sharp object from the outside of the device.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82150601 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 - unable to inflate¿ and subsequent findings of ¿balloon burst¿ were confirmed via device analysis as a leakage was noted due to a rupture on the mid portion of the balloon.The outer surface of the balloon presented evidence of scratch marks adjacent to the rupture 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 balloon of a 10mm x 4cm x 135 powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter did not inflate when the physician went to inflate it.There was no reported patient injury and the device was returned for evaluation.Addendum: product evaluation revealed a rupture to the mid portion of the balloon.

• Brand Name: POWERFLEXPRO 10MM4CM 135
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14160587
• Report Number: 9616099-2022-05561
• Device Sequence Number: 2946090
• Product Code: LIT
• UDI-Device Identifier: 20705032060063
• UDI-Public: 20705032060063
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/20/2022

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: 01/31/2021
• Device Model Number: 4401004X
• Device Catalogue Number: 4401004X
• Device Lot Number: 82150601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2022
• Initial Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male