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

Model Number	39347-120470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture and stent expansion failure occurred.The patient experienced may thurner syndrome.The 59% stenosed target lesion with around 5mm diameter was located in the mildly tortuous and compressed calcified distal external iliac vein.A 16x4x75 xxl esophageal balloon catheter was used to expand the wallstent in the common and external iliac vein.The stent was fully re-constrained; however, the wallstent did not expand sufficiently and in addition, a 12.0mm x 40mm x 75cm athletis balloon catheter was used.But during second inflation at 8 atmospheres for 5 seconds, the balloon ruptured.The device was removed with no fragments left inside the patient and the procedure was completed with another of same athletis balloon.No patient complications were reported.
Additional Manufacturer Narrative
D2b: product code: dqy.Device evaluated by mfr: an athletis device was received for analysis and the following attributes were examined.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 20 atmospheres as per athletis specification.The returned device was attached to an encore inflation unit.Positive pressure was applied when water was observed to be leaking from a balloon pinhole located approximately 1mm distal from the distal markerband.A visual and tactile examination identified no kinks or damage to the shaft.A visual and tactile examination identified no damage to the tip.

• 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: 17645712
• Report Number: 2124215-2023-43066
• Device Sequence Number: 14861117
• Product Code: LIT
• UDI-Device Identifier: 08714729974260
• UDI-Public: 08714729974260
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/29/2023

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: 05/30/2025
• Device Model Number: 39347-120470
• Device Catalogue Number: 39347-120470
• Device Lot Number: 0029500896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2022
• 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