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

Model Number	39347-080450
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.A 8.00mm x 40mm x 50cm athletis percutaneous transluminal angioplasty balloon dilation catheter was selected for the treatment of a shunt failure in the cephalic subclavian vein.The lesion was located in a moderately tortuous anatomy, 75% stenosed and moderately calcified.During the procedure, the balloon was inflated twice to 20 atmospheres (atms).During the second inflation, the balloon ruptured.The device was removed without any problems using the normal method.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).Initial reporter state: (b)(6).
Additional Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).E1.Initial reporter state: (b)(6).Device eval by manufacturer: the returned device consisted of an athletis balloon.Visual examination of the device identified that the balloon was not folded, which indicates that the device was subjected to positive pressure.Visual examination of the balloon material, tip and marker bands identified no issues.There were no damage or kinks identified along the shaft.A leak test identified a pinhole in the balloon material.There were no other issues identified during product analysis.
Event or Problem Description
It was reported that a balloon rupture occurred.A 8.00mm x 40mm x 50cm athletis percutaneous transluminal angioplasty balloon dilation catheter was selected for the treatment of a shunt failure in the cephalic subclavian vein.The lesion was located in a moderately tortuous anatomy, 75% stenosed and moderately calcified.During the procedure, the balloon was inflated twice to 20 atmospheres (atms).During the second inflation, the balloon ruptured.The device was removed without any problems using the normal method.The procedure was completed with another of the same 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: 13945608
• Report Number: 2134265-2022-03103
• Device Sequence Number: 15079377
• Product Code: LIT
• UDI-Device Identifier: 08714729974048
• UDI-Public: 08714729974048
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2022

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: 09/13/2024
• Device Model Number: 39347-080450
• Device Catalogue Number: 39347-080450
• Device Lot Number: 0028014995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2022
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2021
• 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