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

Model Number	39347-080470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture had occurred.A dilation was being performed on a 90% stenosed, moderately calcified and moderately tortuous lesion in the common iliac artery.The 8.0 mm x 40mm athletis balloon ruptured on the third inflation at eight atmospheres.The procedure was successfully completed without patient injury.
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.Blood was present in the balloon.A leak test identified a balloon pinhole located at the proximal edge of the proximal markerband.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.
Event or Problem Description
It was reported that a balloon rupture had occurred.A dilation was being performed on a 90% stenosed, moderately calcified and moderately tortuous lesion in the common iliac artery.The 8.0 mm x 40mm athletis balloon ruptured on the third inflation at eight atmospheres.The procedure was successfully completed without patient injury.

• 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: 12620622
• Report Number: 2134265-2021-12693
• Device Sequence Number: 19134025
• Product Code: LIT
• UDI-Device Identifier: 08714729974055
• UDI-Public: 08714729974055
• 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,foreig
• 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: 05/17/2022
• Device Model Number: 39347-080470
• Device Catalogue Number: 39347-080470
• Device Lot Number: 0026385267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 10/12/2021
• 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