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	04/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b - pro code (product code): lit, dqy.
Event or Problem Description
It was reported that balloon rupture occurred.A 12.0mm x 40mm x 75cm athletis pta balloon dilatation catheter was advanced for dilation.During the procedure, before the balloon reached medium pressure, it ruptured.The device was taken out and the patient was re-treated for another of the same device to complete the procedure.There were no abnormalities or patient complications reported.
Additional Manufacturer Narrative
D2b pro code (product code): lit, dqy.
Event or Problem Description
It was reported that balloon rupture occurred.A 12.0mm x 40mm x 75cm athletis pta balloon dilatation catheter was advanced for dilation.During the procedure, before the balloon reached medium pressure, it ruptured.The device was taken out and the patient was re-treated for another of the same device to complete the procedure.There were no abnormalities or patient complications reported.It was further reported that the target lesion was 70% stenosed and was located in the mildly tortuous and mildly calcified cephalic vein.The balloon ruptured at 12 atmospheres for 30 seconds.The patient's current status is good.

• 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: 19353979
• Report Number: 2124215-2024-30174
• Device Sequence Number: 18009035
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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: 05/11/2025
• Device Model Number: 39347-120470
• Device Catalogue Number: 39347-120470
• Device Lot Number: 0029389743
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2022
• 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: 69 YR
• Patient Sex: Male