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

Model Number	39347-060470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date: the event date is not available and was reported as either (b)(6) 2021 or (b)(6) 2021.
Event or Problem Description
It was reported that the balloon burst.The target lesion was located in the superficial femoral artery (sfa).Stenosis was estimated at 50% target lesion was 80% calcified with no tortuosity.A 6.0mm x 40mm x 75cm athletis balloon was selected for use in a sfa angioplasty procedure to post-dilate a stent.After the stent was implanted, the athletis balloon was inflated once to a pressure between 10-12 atmospheres.However, the balloon burst.The procedure was completed with recanalization.There were no patient consequences.
Event or Problem Description
It was reported that the balloon burst.The target lesion was located in the superficial femoral artery (sfa).Stenosis was estimated at 50% target lesion was 80% calcified with no tortuosity.A 6.0mm x 40mm x 75cm athletis balloon was selected for use in a sfa angioplasty procedure to post-dilate a stent.After the stent was implanted, the athletis balloon was inflated once to a pressure between 10-12 atmospheres.However, the balloon burst.The procedure was completed with recanalization.There were no patient consequences.
Additional Manufacturer Narrative
B3 - event date: the event date is not available and was reported as either (b)(6) 2021 or (b)(6) 2021.Upon receipt at our post market quality assurance laboratory, this athletis 6.0mm x 40mm x 75cm device was examined.Visual examination of the balloon 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 40 atmospheres as per athletis 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 14mm distal from the proximal markerband.A visual and microscopic examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination identified no kinks or damage to the shaft or tip, which may have potentially contributed to the complaint incident.

• 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: 11873371
• Report Number: 2134265-2021-06622
• Device Sequence Number: 13683556
• Product Code: LIT
• UDI-Device Identifier: 08714729973799
• UDI-Public: 08714729973799
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 07/15/2021

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: 05/24/2022
• Device Model Number: 39347-060470
• Device Catalogue Number: 39347-060470
• Device Lot Number: 0026421218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 07/15/2021
• Patient Sequence Number: 1
• Patient Age: 80 YR