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

Model Number	39347-080450
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon ruptured.An 8mm x 40mm x 50cm athletis pta balloon dilatation catheter was selected for use in the basilic vein.The 90% stenosed target lesion was not calcified and located in moderately tortuous anatomy.During the procedure, a pinhole rupture occurred when attempting to remove the device.The procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that the balloon ruptured.An 8mm x 40mm x 50cm athletis pta balloon dilatation catheter was selected for use in the basilic vein.The 90% stenosed target lesion was not calcified and located in moderately tortuous anatomy.During the procedure, a pinhole rupture occurred when attempting to remove the device.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that the balloon was inflated three times.On the first inflation, the balloon was inflated for 60 seconds at a pressure of 15 atmospheres.On the second inflation, the balloon was inflated for 60 seconds at a pressure of 20 atmospheres.During the third inflation, the balloon ruptured at 20 atmospheres.The balloon was removed from the body and re-inserted between inflations.Post rupture, the balloon was successfully removed from the patient.
Additional Manufacturer Narrative
Device eval by manufacturer: athletis 8.0mm x 40mm x 50cm 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 microscopic examination identified a balloon pinhole located approximately at the proximal edge of the distal markerband.An examination of the balloon material and distal markerband identified no issues which could potentially have contributed to this complaint.As per athletis specification, the rated burst pressure for this device is 31 atmospheres.A visual and microscopic 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.No other issues were identified during analysis.

• Brand Name: ATHLETIS PTA BALLOON DILATATION CATHETER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12369786
• Report Number: 2134265-2021-10725
• Device Sequence Number: 4814798
• Product Code: LIT
• UDI-Device Identifier: 08714729974048
• UDI-Public: 08714729974048
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2021

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: 04/22/2024
• Device Model Number: 39347-080450
• Device Catalogue Number: 39347-080450
• Device Lot Number: 0027195951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1