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

Model Number 39347-080450

Device Problems Material Rupture (1546); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2024

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred while interacting with another device.The patient underwent a vascular access intervention therapy for a restenosis of a wallstent rp implanted at another facility several years ago.The 75% stenosed target lesion was located in the moderately tortuous and mildly calcified cephalic arch.A 8.0mm x 40mm x 50cm athletis balloon catheter was advanced for dilation.At the time the device was on ongoing use, the balloon ruptured.It is possible that this was caused by the sharp stent edge of the implanted wallstent.The device was removed and replaced for another of the same model to complete the procedure.There were no complications reported, and patient status was stable.

Manufacturer Narrative

D2b - pro code (product code): dqy.

• Brand Name: ATHLETIS PTA BALLOON DILATATION CATHETER
• Type of Device: 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: 18987580
• MDR Text Key: 338751856
• Report Number: 2124215-2024-17671
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729974048
• UDI-Public: 08714729974048
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 39347-080450
• Device Catalogue Number: 39347-080450
• Device Lot Number: 0032333974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1