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

Model Number	83912
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device eval by manufacturer: the product was returned to boston scientific for analysis.The delivery wire returned.No delivery sheath was returned.Microscopic analysis showed that the perforations were intact.The delivery wire was returned with the proximal and distal couplers attached.The coil was stretched and separated from the distal coupler.Additionally, the stretch-resistant suture was broken at the distal coupler.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2024.It was reported that the coil prematurely deployed inside the microcatheter.An 8mm x 60cm embold soft detachable coil system and a 60cm embold packing detachable coil system were selected for use in a coil embolization procedure to treat a pseudoaneurysm.The anatomy was tortuous.A truselect microcatheter was used to deliver the 8mm x 60 cm embold soft coil first.However, it was determined that the coil was undersized, so it was retracted back into the microcatheter.The coil prematurely deployed from the delivery wire.The microcatheter was pulled out with the deployed coil inside, and access was lost.After access was re-gained, and embold fibered coil was successfully deployed.Following that, the 60cm embold packing coil was advanced.The coil was not sitting like the physician wanted, so the coil was retracted.The coil prematurely deployed, and the microcatheter was pulled to remove the coil.After access was re-gained, the case was completed with non-boston scientific coils.One of the non-boston scientific coils also prematurely deployed during this case.No patient complications were reported.However, device analysis revealed that the 8mm x 60cm embold soft coil was separated from the distal coupler.

• Brand Name: EMBOLD SOFT 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: 19209484
• Report Number: 2124215-2024-25411
• Device Sequence Number: 15435583
• Product Code: KRD
• UDI-Device Identifier: 00191506026578
• UDI-Public: 00191506026578
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 04/29/2024

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 Expiration Date: 08/16/2026
• Device Model Number: 83912
• Device Catalogue Number: 83912
• Device Lot Number: 0033042234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Female