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

Model Number	39347-081070
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon ruptured.An 8mm x 100mm x 75cm athletis pta balloon dilatation catheter was selected for use in a percutaneous transluminal angioplasty (pta) procedure in an arteriovenous (av) graft.The target lesion was 70% stenosed with no calcification.During the procedure, the balloon was inflated for one minute.On the second inflation, the balloon deflated almost immediately before reaching 20atm.The balloon was successfully removed.The procedure was completed with another of the same device.No patient complications were reported, and the patient was in stable condition post procedure.
Additional Manufacturer Narrative
Device eval by manufacturer: the athletis device was received for analysis.Based on the event, the balloon markerbands, tip, shaft, and markerbands were examined.A visual examination of the balloon markerbands identified that the balloon was not folded which indicates that the device was subjected to positive pressure.The returned device was attached to an encore inflation unit.Positive pressure was applied and liquid was observed to be leaking from a balloon pinhole, located approximately 15mm proximal of the distal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this event.A visual and microscopic examination observed no damage to the tip of the device.A visual and tactile examination 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 analysis.
Event or Problem Description
It was reported that the balloon ruptured.An 8mm x 100mm x 75cm athletis pta balloon dilatation catheter was selected for use in a percutaneous transluminal angioplasty (pta) procedure in an arteriovenous (av) graft.The target lesion was 70% stenosed with no calcification.During the procedure, the balloon was inflated for one minute.On the second inflation, the balloon deflated almost immediately before reaching 20atm.The balloon was successfully removed.The procedure was completed with another of the same device.No patient complications were reported, and the patient was in stable condition post procedure.It was further reported that the first inflation was at about 10 to 15 atmospheres (atm), to create a passage.During the second inflation at the treatment site, the balloon reached about 19 atm.The physician locked and set the inflation device down and the balloon deflated immediately and quickly.

• 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: 11423179
• Report Number: 2134265-2021-02784
• Device Sequence Number: 2870199
• Product Code: LIT
• UDI-Device Identifier: 08714729974116
• UDI-Public: 08714729974116
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 04/07/2021

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: 03/28/2022
• Device Model Number: 39347-081070
• Device Catalogue Number: 39347-081070
• Device Lot Number: 0026099725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 04/07/2021
• Patient Sequence Number: 1
• Patient Age: 63 YR