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

Model Number 39347-080450

Device Problem Leak/Splash (1354)

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

Event Date 11/06/2021

Event Type  malfunction  

Event Description

It was reported the balloon ruptured.An 8.0mm x 40mm x 50cm athletis balloon catheter was used to treat a previously placed wallstent in the cephalic vein that was 75% stenosed, moderately tortuous, and mildly calcified.The athletis balloon was advanced to the target lesion, inflated to 12atm and then ruptured.The damage was noted to be the shape of a pinhole.The procedure was completed with another athletis balloon.The patient was reported in good condition.

Manufacturer Narrative

Device evaluated by manufacturer: a visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The rated burst pressure for this device is 31 atmospheres as per specification.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 5mm distal from the distal markerband.A visual and tactile examination identified no kinks or damage to the shaft or tip which may have potentially contributed to the complaint incident.

Event Description

It was reported the balloon ruptured.An 8.0mm x 40mm x 50cm athletis balloon catheter was used to treat a previously placed wallstent in the cephalic vein that was 75% stenosed, moderately tortuous, and mildly calcified.The athletis balloon was advanced to the target lesion, inflated to 12atm, ruptured, and was noted to be the shape of a pinhole.The procedure was completed with another athletis balloon.The patient was reported in good condition.

• Brand Name: ATHLETIS PTA BALLOON DILATATION CATHETER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12900796
• MDR Text Key: 281518356
• Report Number: 2134265-2021-14951
• Device Sequence Number: 1
• Product Code: DQY
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• 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: 0027223744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2021
• 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