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

Model Number	39347-051050
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in the mildly tortuous and severely calcified left forearm.A 5.0mm x 100mm x 50cm athletis balloon catheter was advanced for dilation.During the procedure, on the first inflation at about 30 atmospheres for 30 seconds, the balloon ruptured.The device was successfully removed.The rupture was found to be in the shape of a pinhole.The procedure was completed using another of the same device.No complications reported, and patient status was good.
Additional Manufacturer Narrative
D2b: pro code (product code) - lit, dqy.Device evaluated by mfr.: the device was returned for analysis and underwent a visual and tactile examination.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 20mm proximal of the distal markerband.The rated burst pressure for this device is 40 atmospheres.There were no damages found on the tip, shaft, or markerbands of the device.

• 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: 19951748
• Report Number: 2124215-2024-49064
• Device Sequence Number: 8839436
• Product Code: LIT
• UDI-Device Identifier: 08714729973720
• UDI-Public: 08714729973720
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/09/2024

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 Model Number: 39347-051050
• Device Catalogue Number: 39347-051050
• Device Lot Number: 0033805404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON CATHETER: ATHLETIS5-100; GUIDEWIRE: RADIFOCUS035; INFLATION DEVICE: ANCHOR40; INTRODUCER SHEATH: VAIVT ACE 6FR
• Patient Sex: Unknown