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

Model Number	39347-081070
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon would not deflate.An athletis 8.0mm x 100mm x 75cm pta balloon dilation catheter was selected for use in an arteriovenous (av) fistulagram procedure for treatment of venous stenosis.The physician indicated that after completion of the angioplasty, the balloon would not deflate even after multiple attempts using a large syringe and the inflation device.The sheath was removed, and the inflated balloon was retracted through the skin at the access site.The patient experienced pain at the access site upon removal of the balloon, and anesthesia was used for pain intervention.The procedure was able to be completed successfully without sequela.
Event or Problem Description
It was reported that the balloon would not deflate.An athletis 8.0mm x 100mm x 75cm pta balloon dilation catheter was selected for use in an arteriovenous (av) fistulagram procedure for treatment of venous stenosis.The physician indicated that after completion of the angioplasty, the balloon would not deflate even after multiple attempts using a large syringe and the inflation device.The sheath was removed, and the inflated balloon was retracted through the skin at the access site.The patient experienced pain at the access site upon removal of the balloon, and anesthesia was used for pain intervention.The procedure was able to be completed successfully without sequela.
Additional Manufacturer Narrative
Device/media analysis: a visual examination identified that the balloon had been subjected to positive pressure.No issues were identified with the balloon material, tip or markerbands of the device.The investigator successfully inflated the device to its rated burst pressure and deflated it within the athletis specifications.The shaft of the device was found to be crushed/damaged.No other issues were noted during analysis.As the investigator successfully inflated the balloon to its rated burst pressure and deflated it without issue and within the specified time, the complaint incident cannot be confirmed.It is possible that the damage to the shaft caused the deflation time to be slower and user did not allow sufficient time for the balloon to fully deflate before attempting to remove it from the patient, but this cannot be confirmed.The unreported shaft damage noted during device analysis most likely occurred due to an interaction between the user and the device (unintended), at which stage of the procedure it occurred (during procedure/handling pre or post procedure) cannot be established.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13010136
• Report Number: 2134265-2021-15626
• Device Sequence Number: 19274011
• Product Code: DQY
• UDI-Device Identifier: 08714729974116
• UDI-Public: 08714729974116
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2022

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: 04/26/2024
• Device Model Number: 39347-081070
• Device Catalogue Number: 39347-081070
• Device Lot Number: 0027212384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown