MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ATHLETIS PTA BALLOON DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	39347-100470
Medical Device Problem Codes	Material Rupture (1546); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon burst inside a stent.A 10mm x 40mm x 75cm athletis pta balloon dilatation catheter was selected for use in an angioplasty procedure to treat an occlusion in the superficial femoral artery (sfa).During the procedure, the balloon burst while dilating a stent.The procedure was successfully completed.No patient complications were reported.
Additional Manufacturer Narrative
Device eval by manufacturer: a visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A microscopic examination identified a pinhole in the balloon material.An examination of the balloon material, tip and markerbands identified no issues which could potentially have contributed to this complaint.No kinks or damage were noted along the shaft of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the balloon burst inside a stent.A 10mm x 40mm x 75cm athletis pta balloon dilatation catheter was selected for use in an angioplasty procedure to treat an occlusion in the superficial femoral artery (sfa).During the procedure, the balloon burst while dilating a stent.The procedure was successfully completed.No patient complications were reported.It was further reported that the athletis balloon was inflated 3 times for 50 second durations at 40atm inside a non-boston scientific transjugular intrahepatic portosystemic shunt (tips) stent.The device was successfully removed from the patient, and a mustang balloon was used to complete the procedure.

• Brand Name: ATHLETIS PTA BALLOON DILATATION CATHETER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11850048
• Report Number: 2134265-2021-06443
• Device Sequence Number: 11703863
• Product Code: LIT
• UDI-Device Identifier: 08714729974215
• UDI-Public: 08714729974215
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2021

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: 08/01/2022
• Device Model Number: 39347-100470
• Device Catalogue Number: 39347-100470
• Device Lot Number: 0026739991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 07/06/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10MM GORE VIATORR TIPS.