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

Model Number	83910
Medical Device Problem Codes	Break (1069); Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil fractured during deployment and additional intervention was required.A 3x6 embold fibered detachable coil system was selected for use in a superior rectal artery embolization procedure.The vessel was mildly tortuous.Several embold coils were placed without issue.While advancing the final embold coil, there was resistance encountered.The coil was re-sheathed, and advancement was attempted for a second time, which went more smoothly.When the coil was deployed, it stretched and broke off, with a portion of the coil deploying into the artery and a portion remaining within the microcatheter.The fractured piece of the coil that was within the artery was snared out.All pieces of the device were successfully removed from the patient.There were no reported patient complications and the patient fully recovered.
Event or Problem Description
It was reported that the coil fractured during deployment and additional intervention was required.A 3x6 embold fibered detachable coil system was selected for use in a superior rectal artery embolization procedure.The vessel was mildly tortuous.Several embold coils were placed without issue.While advancing the final embold coil, there was resistance encountered.The coil was re-sheathed, and advancement was attempted for a second time, which went more smoothly.When the coil was deployed, it stretched and broke off, with a portion of the coil deploying into the artery and a portion remaining within the microcatheter.The fractured piece of the coil that was within the artery was snared out.All pieces of the device were successfully removed from the patient.There were no reported patient complications and the patient fully recovered.
Additional Manufacturer Narrative
Device analysis: the product was returned to boston scientific for analysis.Returned product consisted of an embold fibered coil 3x6 only.No other components of the device were returned.Microscopic analysis showed that the coil was stretched.No other damage was noted on the coil; the tip was intact, and the distal coupler was intact.There were no breaks or separations on the returned coil.The coil was severely stretched and still connected to the distal coupler.The distal coupler showed a slight bend.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The complaint was not confirmed for coil advancing or breaks on the coil; however, stretching was confirmed.

• 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: 19095914
• Report Number: 2124215-2024-21535
• Device Sequence Number: 7268805
• Product Code: KRD
• UDI-Device Identifier: 08714729983545
• UDI-Public: 08714729983545
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 83910
• Device Catalogue Number: 83910
• Device Lot Number: 0033138586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2024
• 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: 2.4 PROGREAT; MICROCATHETER: 2.4 PROGREAT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female