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

Model Number	83910
Medical Device Problem Codes	Premature Activation (1484); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 02may2023.It was reported that premature deployment occurred.A 10x50 embold fibered detachable coil system was selected for an embolization of the renal arteriovenous (av) fistula.The device was advanced and at approximately 50% deployment, the device became resistant and stuck.The push wire was not deployed; however, became detached from the coil and was half in the microcatherer and half in the vessel.A v-18 guidewire was advance to attempt to push the coil out of the microcatheter, but became stuck with the coil.The entire system was removed with the coil half in the microcatheter and stuck with guidewire.The procedure was completed with embold coils.There were no patient complications and the patient status was good.However, device analysis revealed the main coil detached.
Additional Manufacturer Narrative
Device evaluated by mfr: the product was returned to boston scientific for analysis.The returned product consisted of an embold fibered coil 10x50.The terumo microcatheter used in the procedure was returned.The nitinol delivery wire was returned with the couplers attached.The delivery sheath was not returned.The returned delivery wire showed that it was not broken at the laser cut perforations.The pull wire was intact.The coil was detached from the distal coupler.The coil was inside of the terumo microcatheter and sticking out to the hub end of the catheter.The coil was pulled from the microcatheter with no issues.The coil showed severe stretching.The coupler components were bent.The returned terumo microcatheter internal diameter was measured using calibrated gage pins and was with in specification.Inspection of the remainder of the device apart from the observed damage, revealed no other damage or irregularities.

• Brand Name: EMBOLD FIBERED DETACHABLE COIL SYSTEM
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17010496
• Report Number: 2124215-2023-26622
• Device Sequence Number: 20591043
• Product Code: KRD
• UDI-Device Identifier: 08714729983651
• UDI-Public: 08714729983651
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/26/2023

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: 10/27/2025
• Device Model Number: 83910
• Device Catalogue Number: 83910
• Device Lot Number: 0030442220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER: 2.8F TERUMO PROGREAT MC
• Patient Age: 49 YR
• Patient Sex: Female