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

Model Number	39347-080850
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
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.The target lesion was located in a non-tortuous and non-calcified vessel.An 8.0mm x 80mm x 50cm athletis pta balloon dilatation catheter was advanced for dilation.During the procedure, the balloon was inserted and ruptured upon first inflation at 20 atmospheres for few seconds.The device was successfully removed, and the procedure was completed with another balloon.No complications were reported, and patient was stable.
Additional Manufacturer Narrative
D2b pro code (product code): lit, dqy.Device evaluated by mfr.: an atletis 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.A visual examination identified a longitudinal tear in the mid region of the balloon and measured approximately 4mm in length.A visual and tactile examination identified no kinks or damage to the shaft.A visual and tactile examination identified no damage to the tip.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a non-tortuous and non-calcified vessel.An 8.0mm x 80mm x 50cm athletis pta balloon dilatation catheter was advanced for dilation.During the procedure, the balloon was inserted and ruptured upon first inflation at 20 atmospheres for few seconds.The device was successfully removed, and the procedure was completed with another balloon.No complications were reported, and patient was stable.

• 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: 19286114
• Report Number: 2124215-2024-27439
• Device Sequence Number: 12868357
• Product Code: LIT
• UDI-Device Identifier: 08714729974086
• UDI-Public: 08714729974086
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup
• Report Date (Section B): 05/22/2024

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: 09/24/2026
• Device Model Number: 39347-080850
• Device Catalogue Number: 39347-080850
• Device Lot Number: 0032495908
• 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: 04/15/2024
• Supplement Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2023
• 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 Sex: Female