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

Model Number	39347-120470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pro code (product code): lit, dqy.
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent percutaneous transluminal angioplasty (pta).The 70% stenosed target lesion was located in the moderately tortuous and moderately calcified radial arteriovenous fistula.A 12.0mm x 40mm x 75cm athletis pta balloon dilatation catheter was advanced for dilatation.However, during the first inflation at 23 atmospheres in 20 seconds, the balloon burst.The procedure was completed with another of same device.No patient complications reported, and the patient condition was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent percutaneous transluminal angioplasty (pta).The 70% stenosed target lesion was located in the moderately tortuous and moderately calcified radial arteriovenous fistula.A 12.0mm x 40mm x 75cm athletis pta balloon dilatation catheter was advanced for dilatation.However, during the first inflation at 23 atmospheres in 20 seconds, the balloon burst.The procedure was completed with another of same device.No patient complications reported, and the patient condition was stable.
Additional Manufacturer Narrative
D2b - pro code (product code): lit, dqy.Device evaluated by manufacturer: an athletis device was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The rated burst pressure for this device is 20 atmospheres as per athletis specification.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 12mm distal from the proximal markerband.A visual and tactile examination identified no kinks or damage to the shaft.A visual and tactile examination identified no damage to the tip.

• Brand Name: ATHLETIS PTA BALLOON DILATATION CATHETER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16728003
• Report Number: 2124215-2023-15136
• Device Sequence Number: 17965266
• Product Code: LIT
• UDI-Device Identifier: 08714729974260
• UDI-Public: 08714729974260
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 05/22/2023

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: 05/12/2025
• Device Model Number: 39347-120470
• Device Catalogue Number: 39347-120470
• Device Lot Number: 0029395792
• 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: 03/24/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2022
• 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 Age: 64 YR
• Patient Sex: Female