MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COIL PUSHER-16; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83785
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil pusher broke.A 177cm coil pusher-16 was selected for use in a coiling embolization procedure in the pelvis with 45 degrees of tortuosity.During the procedure, while pushing the second coil forward, the coil pusher broke in two pieces inside the catheter.Both pieces of the coil pusher were easily removed from the catheter.The procedure was successfully completed with another coil pusher.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluation by manufacturer: the pusher wire was returned for analysis and found broken.The device was measured and the total length was noted to be out of specification, due to the broken condition of the pusher wire.No additional damages were found.
Event or Problem Description
It was reported that the coil pusher broke.A 177cm coil pusher-16 was selected for use in a coiling embolization procedure in the pelvis with 45 degrees of tortuosity.During the procedure, while pushing the second coil forward, the coil pusher broke in two pieces inside the catheter.Both pieces of the coil pusher were easily removed from the catheter.The procedure was successfully completed with another coil pusher.No patient complications were reported.

• Brand Name: COIL PUSHER-16
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11560054
• Report Number: 2134265-2021-03453
• Device Sequence Number: 11502031
• Product Code: KRD
• UDI-Device Identifier: 08714729158967
• UDI-Public: 08714729158967
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K102714
• 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): 07/29/2021

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: 12/24/2022
• Device Model Number: 83785
• Device Catalogue Number: 83785
• Device Lot Number: 0025096444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2021
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 07/29/2021
• Patient Sequence Number: 1