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

Model Number	83910
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	09/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that vessel dissection occurred.A 2mm x 4cm embold fibered detachable coil system was selected for use in a lower gastrointestinal bleed embolization procedure.An attempt was made to embolize a small branch off the superior mesenteric artery (sma).The vessel was moderately tortuous.A 130cm truselect microcatheter with a bern tip and a fathom 16 guidewire were used to select the vessel.An angiogram was performed, and the bleeding vessel was identified.The caliber of the vessel measured 3mm, so the physician opted for a 3mm x 6cm embold fibered detachable coil system.There was no resistance during advancement of the coil.Once the coil exited the truselect, it started to form as it should.Approximately 1/2 of the coil was deployed when it kicked the truselect back.Attempts were made to reposition and retract the coil to get it to seat better, but this method was unsuccessful, and access to the vessel with the truselect was lost.The 3mm x 6cm embold coil was recaptured without difficulty.Another angiogram was taken, and it was noticed the vessel spasmed a little.The physician regained access to the vessel with the fathom guidewire and the truselect and decided to try this 2mm x 4cm embold coil instead.There was no difficulty advancing the coil into the microcatheter and vessel.However, after 2/3 of the coil was out of the truselect, similar resistance was met, and the physician felt the vessel dissected while trying to pack the coil.The microcatheter was kicked out again.The 2mm x 4cm coil was recaptured without difficulty.Another angiogram was taken; it was confirmed that the spasmed vessel was now dissected, and the physician was unable to regain access to the vessel.The dissection of the small branch off the sma was flow-limiting.At this point, the case was aborted.No active bleeding was noted; however, the dissection may have been responsible for the bleeding to stop.Therefore, no action was taken to treat the dissection.No patient symptoms were reported.The patient was stable and fully recovered.The patient will be monitored.
Event or Problem Description
It was reported that vessel dissection occurred.A 2mm x 4cm embold fibered detachable coil system was selected for use in a lower gastrointestinal bleed embolization procedure.An attempt was made to embolize a small branch off the superior mesenteric artery (sma).The vessel was moderately tortuous.A 130cm truselect microcatheter with a bern tip and a fathom 16 guidewire were used to select the vessel.An angiogram was performed, and the bleeding vessel was identified.The caliber of the vessel measured 3mm, so the physician opted for a 3mm x 6cm embold fibered detachable coil system.There was no resistance during advancement of the coil.Once the coil exited the truselect, it started to form as it should.Approximately 1/2 of the coil was deployed when it kicked the truselect back.Attempts were made to reposition and retract the coil to get it to seat better, but this method was unsuccessful, and access to the vessel with the truselect was lost.The 3mm x 6cm embold coil was recaptured without difficulty.Another angiogram was taken, and it was noticed the vessel spasmed a little.The physician regained access to the vessel with the fathom guidewire and the truselect and decided to try this 2mm x 4cm embold coil instead.There was no difficulty advancing the coil into the microcatheter and vessel.However, after 2/3 of the coil was out of the truselect, similar resistance was met, and the physician felt the vessel dissected while trying to pack the coil.The microcatheter was kicked out again.The 2mm x 4cm coil was recaptured without difficulty.Another angiogram was taken; it was confirmed that the spasmed vessel was now dissected, and the physician was unable to regain access to the vessel.The dissection of the small branch off the sma was flow-limiting.At this point, the case was aborted.No active bleeding was noted; however, the dissection may have been responsible for the bleeding to stop.Therefore, no action was taken to treat the dissection.No patient symptoms were reported.The patient was stable and fully recovered.The patient will be monitored.
Additional Manufacturer Narrative
Device eval by manufacturer: the product was returned to boston scientific for analysis.Visual inspection of the device revealed a stretched coil inside the introducer sheath with no introducer damage.The perforations were intact.Microscopic examination of the device revealed a stretched coil and bent couplers.

• 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: 20472154
• Report Number: 2124215-2024-65019
• Device Sequence Number: 7255136
• Product Code: KRD
• UDI-Device Identifier: 08714729983521
• UDI-Public: 08714729983521
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 01/08/2025

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: 0033090407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Race: White