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

Model Number	39347-120670
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.The target lesion was located in the central vessel.A 12.0mm x 60mm x 75cm athletis balloon catheter was advanced for dilatation.However, during the procedure, the balloon was ruptured.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the athletis balloon was returned for analysis.A visual examination identified that the balloon was not folded, which indicates that the device was subjected to positive pressure.A leak test identified a balloon pinhole located approximately 12mm proximal of the distal tip.The rated burst pressure for this device is 20 atmospheres.A visual examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on the shaft of the device.
Event or Problem Description
It was reported that a balloon rupture occurred.The target lesion was located in the central vessel.A 12.0mm x 60mm x 75cm athletis balloon catheter was advanced for dilatation.However, during the procedure, the balloon was ruptured.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that the 70% stenosed target lesion was mildly calcified and located in mildly tortuous anatomy.The balloon ruptured upon the third inflation at rated burst pressure.The device was removed without any problem and the patient was in good condition after the procedure.

• 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: 19335880
• Report Number: 2124215-2024-29410
• Device Sequence Number: 12392106
• Product Code: LIT
• UDI-Device Identifier: 08714729974284
• UDI-Public: 08714729974284
• 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): 06/21/2024

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: 05/02/2025
• Device Model Number: 39347-120670
• Device Catalogue Number: 39347-120670
• Device Lot Number: 0029329109
• 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: 04/23/2024
• Supplement Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2022
• 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: 70 YR
• Patient Sex: Male