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

Model Number	39347-080470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b - additional pro code (product code): dqy.E1 - initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in a shunt in the moderately tortuous and severely calcified subclavian vein.A 7.0mm x 40mm x 75cm and an 8.0mm x 40mm x 75cm athletis pta balloon dilatation catheters were each advanced and inflated to 30 atmospheres for 30 seconds.However, the 7.0mm x 40mm x 75cm balloon ruptured on the fifth inflation and the 8.0mm x 40mm x 75cm balloon ruptured on the initial inflation.The balloons were removed, and the procedure was completed with another of same device.There were no patient complications reported and the patient was in good condition post-procedure.
Additional Manufacturer Narrative
D2b - additional pro code (product code): (b)(6).E1 - initial reporter address 1: (b)(6).Device evaluated by mfr: athletis 8.0mm x 40mm x 75cm, was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.A balloon pinhole was identified located approximately 3mm proximal of the distal markerband.As per athletis specification the rated burst pressure for this device is 31 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.This concludes the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in a shunt in the moderately tortuous and severely calcified subclavian vein.A 7.0mm x 40mm x 75cm and an 8.0mm x 40mm x 75cm athletis pta balloon dilatation catheters were each advanced and inflated to 30 atmospheres for 30 seconds.However, the 7.0mm x 40mm x 75cm balloon ruptured on the fifth inflation and the 8.0mm x 40mm x 75cm balloon ruptured on the initial inflation.The balloons were removed, and the procedure was completed with another of same device.There were no patient complications reported and the patient was in good condition 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: 17206281
• Report Number: 2124215-2023-33283
• Device Sequence Number: 5540546
• Product Code: LIT
• UDI-Device Identifier: 08714729974055
• UDI-Public: 08714729974055
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2023

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: 10/03/2025
• Device Model Number: 39347-080470
• Device Catalogue Number: 39347-080470
• Device Lot Number: 0030272814
• 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: 06/15/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2022
• 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 Sex: Unknown