MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 7MM4CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4400704X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82180880 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 7mm x 4cm 135 powerflex pro percutaneous transluminal angioplasty (pta) dilatation catheter ruptured at 15 atmospheres (atm) during its second inflation attempt.There was no reported patient injury.The lesion was between the right common iliac artery and the external iliac artery.The left brachial artery was punctured.The complaint device was used for pre-dilation and inflated to 10atm for twenty seconds during its initial inflation.Inflation was insufficient therefore, a second inflation was attempted at 15atm for thirty seconds.However, the complaint device ruptured after it was being inflated for fifteen seconds.There was moderate calcification around the lesion.The device will not be returned for evaluation because it was discarded.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h6, and h10.Complaint conclusion: as reported, a 7mm x 4cm 135 powerflex pro percutaneous transluminal angioplasty (pta) dilatation catheter ruptured at 15 atmospheres (atm) during its second inflation attempt.There was no reported patient injury.The lesion was between the right common iliac artery and the external iliac artery.The left brachial artery was punctured.The complaint device was used for pre-dilation and inflated to 10atm for twenty seconds during its initial inflation.Inflation was insufficient; therefore, a second inflation was attempted at 15atm for thirty seconds.However, the complaint device ruptured after it was inflated for fifteen seconds.There was moderate calcification around the lesion.The device will not be returned for evaluation because it was discarded.The product was not returned for analysis as it was discarded.A product history record (phr) review of lot 82180880 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¿ could not be confirmed as the device was not returned for analysis and the exact cause could not be determined.Vessel characteristics, such as moderate calcification, may have contributed to the reported event.However, with the limited amount of information provided and without the return of the device for analysis, it is difficult to draw a clinical conclusion between the device and the event reported.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.¿ the ifu also instructs that inflation at a high rate may damage the balloon.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 7MM4CM 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 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15293729
• Report Number: 9616099-2022-05921
• Device Sequence Number: 11411887
• Product Code: LIT
• UDI-Device Identifier: 20705032059708
• UDI-Public: 20705032059708
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 09/01/2022

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: 10/31/2022
• Device Model Number: 4400704X
• Device Catalogue Number: 4400704X
• Device Lot Number: 82180880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2022
• Supplement Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2019
• 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 Sex: Unknown