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

Model Number	39347-080870
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.An 8.0mm x 80mm x 75cm athletis pta balloon dilatation catheter was selected for an arteriovenous graft (avg) percutaneous transluminal angioplasty (pta) procedure.The target lesion was 80% stenosed.During the first inflation of less than 10 seconds, the balloon ruptured.After decompression, the device was able to be removed from the body and the procedure was completed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
Pro code: lit, dqy.
Event or Problem Description
It was reported that balloon rupture occurred.An 8.0mm x 80mm x 75cm athletis pta balloon dilatation catheter was selected for an arteriovenous graft (avg) percutaneous transluminal angioplasty (pta) procedure.The target lesion was 80% stenosed.During the first inflation of less than 10 seconds, the balloon ruptured.After decompression, the device was able to be removed from the body and the procedure was completed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
Pro code: lit, dqy.

• 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: 13600923
• Report Number: 2134265-2022-01858
• Device Sequence Number: 17629057
• Product Code: LIT
• UDI-Device Identifier: 08714729974093
• UDI-Public: 08714729974093
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2022

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: 08/09/2022
• Device Model Number: 39347-080870
• Device Catalogue Number: 39347-080870
• Device Lot Number: 0026786566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female