MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBOLD FIBERED DETACHABLE COIL SYSTEM; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83910
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned product consisted of an embold fibered 4x15.The renegade microcatheter used in the procedure was returned.The nitinol pusher wire and the pullback wire were returned engaged.The introducer sheath was returned with no damage.The returned pusher wire showed multiple small bends on the distal end as well as damaged couplers.The coupler looked to be bent.The coil was separated from the coupler.The coil was returned stuck inside of the microcatheter.X-ray analysis showed the coil stuck in the catheter lumen.Inspection of the remainder of the device apart from the observed damage revealed no other damage or irregularities.The complaint was not confirmed for advancing/withdrawing issues; however, coil detachment was confirmed.
Event or Problem Description
Reportable based on analysis completed on (b)(6) 2022.It was reported that the coil became entrapped in the microcatheter.An embold fibered 4x15 detachable coil system was selected for the index procedure.The.021 renegade microcatheter was flushed with saline during preparation and no kinks were detected; however, when the coil was advanced halfway through the microcatheter, the coil would not move forward and it couldn't be pulled back.The microcatheter was removed from the patient with the coil still in it.A new microcatheter and new embold coils were used to complete the procedure.There were no patient complications reported.However, device analysis revealed a separated coil.

• Brand Name: EMBOLD FIBERED DETACHABLE COIL SYSTEM
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15139184
• Report Number: 2134265-2022-08240
• Device Sequence Number: 17963474
• Product Code: KRD
• UDI-Device Identifier: 08714729983576
• UDI-Public: 08714729983576
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K213398
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/01/2022

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: 03/08/2025
• Device Model Number: 83910
• Device Catalogue Number: 83910
• Device Lot Number: 0029014501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 08/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown