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

Model Number	39347-061070
Medical Device Problem Codes	Difficult to Advance (2920); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that foreign material was present in the device.A 6mm x 100mm athletis balloon dilatation catheter was selected for use in a shunt percutaneous transluminal angioplasty procedure.The 75% stenosed target lesion was located in moderately tortuous anatomy.The plan was to place a non-boston scientific stent.Pre-dilation was performed with a non-boston scientific guidewire and the athletis balloon.The guidewire was then removed with the athletis left in place.An attempt was made to insert a different non-boston scientific guidewire, but there was resistance in the middle, and it could not be inserted.The guidewire was exchanged for another, but there was strong resistance in the same location, and it could not be inserted.An attempt was then made to insert the original guidewire, but resistance was felt at the same location, and it could not be inserted.The athletis was removed.When it was flushed, a blue residue came out.Target treatment was completed.No patient complications were reported.

• 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: 12302076
• Report Number: 2134265-2021-10219
• Device Sequence Number: 14335643
• Product Code: LIT
• UDI-Device Identifier: 08714729973850
• UDI-Public: 08714729973850
• 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
• Report Date (Section B): 08/10/2021

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: 08/16/2022
• Device Model Number: 39347-061070
• Device Catalogue Number: 39347-061070
• Device Lot Number: 0026825445
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 08/10/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AGURU SUPPORT; BESCROSS