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

Model Number	83912
Medical Device Problem Codes	Stretched (1601); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device eval by manufacturer: returned product consisted of a embold soft coil system.Inspection of the device revealed the coil was stretched and cut.The coil was detached from the distal coupler at the weld.The perforations were intact.The distal and proximal couplers were locked together with the pull wire.The complaint was confirmed for damage consistent with a coil detachment at the weld along with coil stretching/detached.
Event or Problem Description
It was reported that the coil stretched and protruded from the target location.A 6x60 embold soft was selected for use in an embolization procedure of a pancreaticoduodenal artery aneurysm.The aneurysm was packed with multiple coils of various types, which included non-boston scientific coils followed by two 6x60 embold soft coils.Then a third 6x60 embold soft was delivered and packed into the aneurysm.The coil had to be retracted and advanced a bit to get it in the proper location, but in the end, the physician was happy with location in the aneurysm.The coil was detached, but the coil did not separate from the delivery wire; instead, the coil came back with the delivery wire.The couplers were noted to be out of the microcatheter tip when detaching.The physician attempted to advance and retract a bit to try to get the couplers to separate.However, during this process, the coil stretched, and the physician pulled the entire delivery system out of the microcatheter tip.The stretched coil came back with the delivery system.The physician cut the coil wire at the microcatheter hub and pushed the coil wire that remained in the microcatheter into the patient's anatomy.Attempts were made utilizing several methods for hours to get the entire coil into the aneurysm, but it was unsuccessful.Most of the coil was in the aneurysm but some of it hung out into the parent artery.While not ideal, the physician was comfortable leaving the coil where it was.No patient complications were reported.

• 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: 19514955
• Report Number: 2124215-2024-35582
• Device Sequence Number: 7326202
• Product Code: KRD
• UDI-Device Identifier: 00191506026554
• UDI-Public: 00191506026554
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/11/2024

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: 83912
• Device Catalogue Number: 83912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown