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

Model Number	83910
Medical Device Problem Codes	Stretched (1601); Material Protrusion/Extrusion (2979); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: lot number: there were two 8mm x 20cm embold fibered coils placed at the end of the case: lot numbers 34247817 and 33795293.It is unknown which lot number corresponds with the reported event.
Event or Problem Description
It was reported that the coil stretched and protruded from the target location.An 8mm x 20cm embold fibered detachable coil system was selected for use in the embolization of a gastrointestinal bleed in the gastroduodenal artery (gda).Everything went smoothly with the case until this last 8mm x 20cm coil.The microcatheter was within the coil pack during deployment, and the release of the deployment mechanism was uneventful as well.The physician was performing fluoroscopy while retracting and did not notice any issue until he saw that the collars of the deployment mechanism within the microcatheter shaft apparently not separated.He ultimately attempted to snare the mandril, but this was unsuccessful.He abandoned more attempts as he didn't want to potentially dislodge the packing coil that was just distal to this stretched coil.The stretched coil was left in place as there wasn't a better solution to try and retrieve.The procedure was completed.The patient did okay.No further action was planned; they will continue to monitor.
Event or Problem Description
It was reported that the coil stretched and protruded from the target location.An 8mm x 20cm embold fibered detachable coil system was selected for use in the embolization of a gastrointestinal bleed in the gastroduodenal artery (gda).Everything went smoothly with the case until this last 8mm x 20cm coil.The microcatheter was within the coil pack during deployment, and the release of the deployment mechanism was uneventful as well.The physician was performing fluoroscopy while retracting and did not notice any issue until he saw that the collars of the deployment mechanism within the microcatheter shaft apparently not separated.He ultimately attempted to snare the mandril, but this was unsuccessful.He abandoned more attempts as he didn't want to potentially dislodge the packing coil that was just distal to this stretched coil.The stretched coil was left in place as there wasn't a better solution to try and retrieve.The procedure was completed.The patient did okay.No further action was planned; they will continue to monitor.
Additional Manufacturer Narrative
Media analysis: the device was not returned for analysis; however, the site provided fluoroscopic imagery of the suspected broken coil.The fluoroscopic image was reviewed, and it was confirmed that the coil wire had not broken, and the coil had only been stretched.The reported events of stretched coil and coil protruding from the target location were confirmed.D4: lot number: there were two 8mm x 20cm embold fibered coils placed at the end of the case: lot numbers 34247817 and 33795293.It is unknown which lot number corresponds with the reported event.

• 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: 20407659
• Report Number: 2124215-2024-62568
• Device Sequence Number: 19727689
• Product Code: KRD
• UDI-Device Identifier: 08714729983620
• UDI-Public: 08714729983620
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 11/06/2024

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: 0034247817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 11/06/2024
• Date Device Manufactured: 06/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male