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); Separation Failure (2547); Material Protrusion/Extrusion (2979); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil was protruding from the target location requiring additional intervention.An embold fibered 12x20 coil was selected for use to treat a 12mm aneurysm located in a non-tortuous left renal artery.Two embold coils had already been successfully placed in the aneurysm.The 12x20 embold coil was advanced without difficulty and positioned in the aneurysm.The coil was ready to be deployed, however, it would not detach.The physician manipulated the pusher wire back and forth and the coupler was observed past the ro marker band of the renegade stc catheter.The coil appeared to be detached, and the pusher wire and catheter were removed without any difficulty.At this point, a stretched embold coil was seen in the main branch of the renal artery, and the coupler was in the abdominal aorta.A multi-loop snare was used to successfully remove the coil fully intact.A renal angiogram was performed to make sure the renal artery was not compromised from the coil being in the vessel during the time it took to snare the coil.There were no problems observed.The procedure was completed with the two coils that had already been implanted.There were no patient complications.
Event or Problem Description
It was reported that the coil was protruding from the target location requiring additional intervention.An embold fibered 12x20 coil was selected for use to treat a 12mm aneurysm located in a non-tortuous left renal artery.Two embold coils had been already successfully placed in the aneurysm.The 12x20 embold coil was advanced without difficulty and positioned in the aneurysm.The coil was ready to be deployed, however, it would not detach.The physician manipulated the pusher wire back and forth and the coupler was observed past the ro marker band of the renegade stc catheter.The coil appeared to be detached, and the pusher wire and catheter were removed without any difficulty.At this point, a stretched embold coil was seen in the main branch of the renal artery, and the coupler was in the abdominal aorta.A multi-loop snare was used to successfully remove the coil fully intact.A renal angiogram was performed to make sure the renal artery was not compromised from the coil being in the vessel during the time it took to snare the coil.There were no problems observed.The procedure was completed with the two coils that had already been implanted.There were no patient complications.
Additional Manufacturer Narrative
Device eval by mfr: the product was returned for analysis.Returned product consisted of a embold fibered coil system.Inspection of the device revealed the coil was stretched.The wedge lock, introducer sheath and the entire proximal delivery section was removed at the customer site and was not received.Only the coil was received.Inspection of the device revealed the coil was stretched and still attached to the distal coupler with no coupler damage.Media was returned in the form of a photo.Inspection of the media appears to show the device inside the patient under fluoroscopy with the device stretched outside the target lesion.Media review in conjunction with lab analysis was able to confirm the alleged complaint issue.Inspection of the returned device revealed a stretched coil.The complaint was confirmed for a stretched coil consistent with difficulties advancing or withdrawing the device.

• 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: 19828410
• Report Number: 2124215-2024-41913
• Device Sequence Number: 12928069
• Product Code: KRD
• UDI-Device Identifier: 08714729983668
• UDI-Public: 08714729983668
• 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): 09/05/2024

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 Expiration Date: 06/22/2025
• Device Model Number: 83910
• Device Catalogue Number: 83910
• Device Lot Number: 0029641548
• 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: 07/02/2024
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2022
• 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: 51 YR
• Patient Sex: Male
• Patient Race: White