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

Model Number	39347-051070
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon was ruptured.A 5.00 mm x 100 mm x 75 cm athletis was selected for a percutaneous transluminal angioplasty in the shunt.Patient anatomy conditions revealed moderate tortuosity and 75% stenosis.The balloon was inflated three times, at 30 atmospheres (atm), for 60 seconds each.The balloon ruptured at 30 atm while inside the patient.The device was successfully removed from the patient without any problems.The procedure was completed with another device.There were no patient complications reported.

• 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: 12737975
• Report Number: 2134265-2021-13238
• Device Sequence Number: 11794195
• Product Code: LIT
• UDI-Device Identifier: 08714729973737
• UDI-Public: 08714729973737
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/02/2021

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: 03/24/2024
• Device Model Number: 39347-051070
• Device Catalogue Number: 39347-051070
• Device Lot Number: 0027035504
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1