MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO POWERFLEXPRO 10MM4CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	N/A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
During an interventional procedure in the iliac artery, a 10mm x 4cm 135 powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter it ruptured.The procedure was successfully completed with another device.There was no reported patient injury.The device will not be returned as it was discarded by mistake.The access site was the femoral artery.There was no difficulty removing the forming tube off the balloon.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.The balloon catheter was removed easily from the vessel and from the other devices.Additional patient and procedural details were requested but are not available because the sales rep cannot visit the facility due to covid-19.
Additional Manufacturer Narrative
During an interventional procedure in the iliac artery, a 10mm x 4cm 135 powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter ruptured.The procedure was successfully completed with another device.There was no reported patient injury.The access site was the femoral artery.There was no difficulty removing the forming tube off the balloon.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.The balloon catheter was removed easily from the vessel and from the other devices.Additional patient and procedural details were requested but are not available because the sales rep cannot visit the facility due to covid-19.The product was not returned for analysis as it was discarded by mistake.A product history record (phr) review of lot 82187115 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ 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 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: POWERFLEXPRO 10MM4CM 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: 11365271
• Report Number: 9616099-2021-04288
• Device Sequence Number: 19030818
• Product Code: LIT
• UDI-Device Identifier: 20705032060063
• UDI-Public: 20705032060063
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2021

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: N/A
• Device Catalogue Number: 4401004X
• Device Lot Number: 82187115
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/02/2021
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 02/26/2021
• 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.; UNK.