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

Model Number	39347-100470
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 balloon ruptured.The 60% stenosed target lesion was located in the mildly tortuous and mildly calcified left central vein.A 10.0mm x 40mm x 75cm athletis pta balloon dilatation catheter was advanced for dilatation.However, during third inflation at 14 atmospheres for 1 minute, the balloon ruptured.The device was removed using normal method and the procedure was completed with another of the same device.No complications were reported, and the patient was good post procedure.
Additional Manufacturer Narrative
The device was returned for evaluation.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.A balloon pinhole was found, located approximately 33mm proximal of the distal tip.As per specification, the rated burst pressure for this device is 30 atmospheres.A visual examination observed damage to the tip of the device.This type of damage is consistent with the device encountering resistance.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.No other issues were identified with the device and no patient complications were reported.
Event or Problem Description
It was reported that balloon ruptured.The 60% stenosed target lesion was located in the mildly tortuous and mildly calcified left central vein.A 10.0mm x 40mm x 75cm athletis pta balloon dilatation catheter was advanced for dilatation.However, during third inflation at 14 atmospheres for 1 minute, the balloon ruptured.The device was removed using normal method and the procedure was completed with another of the same device.No complications were reported, and the patient was good post 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: 19343627
• Report Number: 2124215-2024-26721
• Device Sequence Number: 7318031
• Product Code: LIT
• UDI-Device Identifier: 08714729974215
• UDI-Public: 08714729974215
• 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): 06/25/2024
• 2 Devices were Involved in the Event: 1 2

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: 06/02/2025
• Device Model Number: 39347-100470
• Device Catalogue Number: 39347-100470
• Device Lot Number: 0029523663
• 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: 05/30/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2022
• 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: 72 YR
• Patient Sex: Male