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

Model Number	39347-120470
Medical Device Problem Codes	Material Rupture (1546); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon ruptured.A 12x40x75 athletis pta balloon was selected for use in a deep venous stenting procedure.The athletis balloon was successfully used three times to pre-dilate before stenting.After placement of a wallstent, the athletis was used for post-dilation.During inflation the balloon ruptured on the edge of the implanted stent.A non-bsc balloon was used to complete the procedure.There were no patient complications.
Additional Manufacturer Narrative
Device eval by manufacturer: 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.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the tip.No kinks or damage were noted along the shaft of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the balloon ruptured.A 12x40x75 athletis pta balloon was selected for use in a deep venous stenting procedure.The athletis balloon was successfully used three times to pre-dilate before stenting.After placement of a wallstent, the athletis was used for post-dilation.During inflation the balloon ruptured on the edge of the implanted stent.A non-bsc balloon was used to complete the procedure.There were no patient complications.It was further reported that the 60% stenosed target lesion was located in the external iliac vein with some tortuosity.The balloon was inflated three times prior to stenting and once after stenting.The balloon was used for pre-dilation prior to stenting, removed from the body, and then re-inserted post stenting.The balloon was inflated lower than rated burst pressure.

• 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: 11977796
• Report Number: 2134265-2021-07474
• Device Sequence Number: 14318740
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2021

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: 06/07/2022
• Device Model Number: 39347-120470
• Device Catalogue Number: 39347-120470
• Device Lot Number: 0026491864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 07/09/2021
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 95