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); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older.Device evaluated by mfr: the returned product consisted of a embold fibered coil system.Visual inspection of the device revealed the coil system was received inside the introducer with dried blood.The wedge lock was removed at the customer site and was not received.The device was received inside the introducer sheath with the perforations intact.Microscopic inspection of the device revealed a stretched/detached and missing coil with the couplers still locked via the pull wire.The couplers were bent/damaged.The majority of the coil was missing and not received.The complaint was confirmed for a stretched/detached coil consistent with difficulties advancing or withdrawing the device.
Event or Problem Description
Reportable based on device analysis completed on 19july2024.It was reported that difficulty advancing and premature deployment in catheter occurred.A 2x4 embold fibered detachable coil system was selected for an embolization procedure of an accessory left gastric artery for arterial mapping for y90 administration.The vessel was mild to moderately tortuous.The first coil was pushed approximately half way through the 2.8fr x 150cm non-boston scientific catheter, with difficulty.The wire was removed, and it was discovered that the coil prematurely deployed in the microcatheter.The microcatheter was removed and cleared.An embold fibered 3x6 was used to successfully complete the procedure.There were no patient complications.However, device analysis revealed a detached coil.

• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19963322
• Report Number: 2124215-2024-49963
• Device Sequence Number: 7080432
• Product Code: KRD
• UDI-Device Identifier: 08714729983521
• UDI-Public: 08714729983521
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/12/2024

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 Model Number: 83910
• Device Catalogue Number: 83910
• Device Lot Number: 0033842588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2024
• 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: 2.8FR X 150CM TERUMO PROGREAT
• Patient Sex: Unknown