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

Model Number	39347-060450
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon ruptured.An athletis 6.0mm x 40mm x 50cm balloon dilatation catheter was selected for use for shunt stenosis in the forearm cephalic vein for vascular access intervention therapy (vaivt).The procedure was being performed to treat 90% stenosis.The target lesion contained moderate calcification and no tortuous severity.The physician inserted the catheter, and upon the second treatment of the area the balloon ruptured after inflation at 20 atm for 30 seconds.The catheter was removed as intended, and surgical observations found a vertical rupture in the balloon.The procedure was able to be completed successfully using a different device without sequela.
Additional Manufacturer Narrative
Pro code: (b)(4).
Event or Problem Description
It was reported that the balloon ruptured.An athletis 6.0mm x 40mm x 50cm balloon dilatation catheter was selected for use for shunt stenosis in the forearm cephalic vein for vascular access intervention therapy (vaivt).The procedure was being performed to treat 90% stenosis.The target lesion contained moderate calcification and no tortuous severity.The physician inserted the catheter, and upon the second treatment of the area the balloon ruptured after inflation at 20 atm for 30 seconds.The catheter was removed as intended, and surgical observations found a vertical rupture in the balloon.The procedure was able to be completed successfully using a different device without sequela.
Additional Manufacturer Narrative
D2b pro code: dqy.Device eval by manufacturer: a visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A visual examination of the balloon identified a longitudinal tear in the balloon material approximately 4mm in length, located in the distal region of the balloon.A visual and tactile examination identified no kinks or damage to the shaft, nor damage to the tip, which may have potentially contributed to the report from the field.The device encountered difficult patient anatomy as it was stated that the lesion was described as 90% stenosed and located in a moderate calcified vessel, which would likely have contributed to the balloon rupture.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15667769
• Report Number: 2124215-2022-43267
• Device Sequence Number: 7142373
• Product Code: LIT
• UDI-Device Identifier: 08714729973782
• UDI-Public: 08714729973782
• 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): 12/08/2022

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: 06/20/2025
• Device Model Number: 39347-060450
• Device Catalogue Number: 39347-060450
• Device Lot Number: 0029625403
• 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: 10/17/2022
• Supplement Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown