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

Model Number	39347-070470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.A 7.0mm x 40mm x 75cm athletis balloon was selected for a procedure in the brachial vein.Patient anatomy conditions revealed moderate tortuosity, 99% stenosis and mild calcification.During the procedure, the balloon was inflated once to 30 atmospheres (atms) for 10 seconds.During this inflation the balloon ruptured.The device was removed without problem using the normal method.The procedure was completed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
Device eval by manufacturer: the athletis balloon was returned to boston scientific for device analysis.Visual examination identified that the balloon had been inflated.Visual inspection did not identify any issues with the balloon material, markerbands, shaft or tip of the device.A leak test did not find a rupture or drop in pressure when the balloon was inflated.The reported clinical observation was not confirmed.
Event or Problem Description
It was reported that a balloon rupture occurred.A 7.0mm x 40mm x 75cm athletis balloon was selected for a procedure in the brachial vein.Patient anatomy conditions revealed moderate tortuosity, 99% stenosis and mild calcification.During the procedure, the balloon was inflated once to 30 atmospheres (atms) for 10 seconds.During this inflation the balloon ruptured.The device was removed without problem using the normal method.The procedure was completed with a different 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12940588
• Report Number: 2134265-2021-15270
• Device Sequence Number: 4955920
• Product Code: LIT
• UDI-Device Identifier: 08714729973911
• UDI-Public: 08714729973911
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2022

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: 04/18/2022
• Device Model Number: 39347-070470
• Device Catalogue Number: 39347-070470
• Device Lot Number: 0026215939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2021
• Supplement Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2020
• 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