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	09/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 7.0mm x 40mm x 75cm athletis balloon catheter was used for the percutaneous transluminal angioplasty procedure.However, during inflation, the balloon burst at 30 atmospheres.The procedure was completed with another of the same device.The patient was treated without any abnormalities.
Additional Manufacturer Narrative
Device evaluated by mfr: athletis 7.0mm x 40mm x 75cm balloon catheter was returned for analysis.A visual examination of the balloon identified that it was not folded and appeared to have been subjected to positive pressure.The pinhole was located approximately 20 mm distal of the proximal markerband, and the rated burst pressure was 34 atmospheres.A visual examination of the tip revealed no damage.A visual and tactile examination of the shaft found no kinks or damage.Both the markerbands were not damaged, and they were present on the shaft of the device.
Event or Problem Description
It was reported that balloon rupture occurred.A 7.0mm x 40mm x 75cm athletis balloon catheter was used for the percutaneous transluminal angioplasty procedure.However, during inflation, the balloon burst at 30 atmospheres.The procedure was completed with another of the same device.The patient was treated without any abnormalities.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17962527
• Report Number: 2124215-2023-56389
• Device Sequence Number: 12668283
• Product Code: LIT
• UDI-Device Identifier: 08714729973911
• UDI-Public: 08714729973911
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2023

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: 03/01/2026
• Device Model Number: 39347-070470
• Device Catalogue Number: 39347-070470
• Device Lot Number: 0031154591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• 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