MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO 244 S DE RL DE CV 8MM4CM 80 POWERFLEXPRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	N/A
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During an interventional procedure, an 8mm x 4cm power flex pro percutaneous transluminal angioplasty (pta) balloon catheter ruptured at 8 atmospheres (atm).Therefore, the device was replaced with a new 8mm x 2cm power flex pro pta balloon and the procedure was completed.There was no reported patient injury.The access site was the femoral.There was no difficulty removing the complaint balloon from the packaging.There were no kinks or other damages noted prior to inserting the product the product into the patient.The device prepped normally.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or while inserting the balloon through the guide catheter.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The balloon catheter did not kink while being used.It was easily removed.Patient information including the reason for the procedure and medical history were requested but were not available.The device will not be returned for evaluation as it was discarded due to infectious disease.
Additional Manufacturer Narrative
(b)(6).Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
During an interventional procedure, an 8mm x 4cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter ruptured at eight atmospheres (atm).Therefore, the device was replaced with a new 8mm x 2cm power flex pro pta balloon and the procedure was completed.There was no reported patient injury.The access site was the femoral.There was no difficulty removing the complaint balloon from the packaging.There were no kinks or other damages noted prior to inserting the product into the patient.The device prepped normally.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or while inserting the balloon through the guide catheter.There was no difficulty advancing the balloon catheter through the vessel or crossing the lesion.The catheter was never in an acute bend.The balloon catheter did not kink while being used.It was easily removed.Patient information including the reason for the procedure and medical history were requested but were not available.The device was not returned for evaluation as it was discarded due to infectious disease.A product history record (phr) review of lot 82226873 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.The exact cause could not be determined.Vessel characteristics, although unknown, may have contributed to the reported event.However, with the limited amount of information provided regarding vessel characteristics 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.¿ 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: 8MM4CM 80 POWERFLEXPRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CARDINAL HEALTH MEXICO 244 S DE RL DE CV; santiago troncoso 808; juarez 32574 ; MX 32574
• Manufacturer (Section G): CARDINAL HEALTH MEXICO 244 S DE RL DE CV; santiago troncoso 808; juarez 32574 ; MX 32574
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12840629
• Report Number: 9616099-2021-05059
• Device Sequence Number: 11849844
• Product Code: LIT
• UDI-Device Identifier: 20705032059814
• UDI-Public: 20705032059814
• 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): 11/19/2021

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: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 4400804S
• Device Lot Number: 82226873
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 11/18/2021
• Supplement Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2021
• 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