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	09/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon ruptured.A 8.0mm x 40mm x 50cm athletis pta balloon dilatation catheter was selected for a patient procedure in the subclavian vein to treat the patient's shunt failure and also in stent restenosis.The lesion was moderately tortuous and 75% stenosed.During the procedure, inside of the patient, the balloon ruptured on the second inflation at 15 atm.The shape of the rupture was a pinhole rupture.The device was removed from the patient using normal methods and without any problems.No additional damage was noted on the device.No patient complications were reported.The patient's condition after the procedure was good.The procedure was completed with another of the same device.
Event or Problem Description
It was reported that the balloon ruptured.A 8.0mm x 40mm x 50cm athletis pta balloon dilatation catheter was selected for a patient procedure in the subclavian vein to treat the patient's shunt failure and also in stent restenosis.The lesion was moderately tortuous and 75% stenosed.During the procedure, inside of the patient, the balloon ruptured on the second inflation at 15 atm.The shape of the rupture was a pinhole rupture.The device was removed from the patient using normal methods and without any problems.No additional damage was noted on the device.No patient complications were reported.The patient's condition after the procedure was good.The procedure was completed with another of the same device.
Additional Manufacturer Narrative
Device evaluated by mfr: a visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.A leak test identified a balloon pinhole located approximately 3mm proximal from the proximal markerband.An examination of the markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination of the tip observed no damage to the tip of the device.A visual and tactile examination of the shaft 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 the product 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: 12563060
• Report Number: 2134265-2021-12160
• Device Sequence Number: 1453807
• 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): 11/03/2021

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: 02/08/2022
• Device Model Number: 39347-080450
• Device Catalogue Number: 39347-080450
• Device Lot Number: 0025848869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 11/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1