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

Model Number	83910
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil became stuck to the catheter tip, and additional intervention was required to remove the coil.A 22 x 60 embold fibered detachable coil system was selected for use in the embolization of a splenic aneurysm.An 021 straight microcatheter was used to gain access to the splenic aneurysm.Upon inserting the coil, the coil started flailing around the aneurysm sac.The physician went to re-sheath the coil and exchange it for a smaller size when the coil stretched and caught on the microcatheter tip.Resistance was experienced during advancement and withdrawal.Ultimately the physician went in through groin access with a snare to remove the coil from the patient's body.Procedure time was prolonged, but the procedure was completed using an alternate device.No patient complications were reported.
Additional Manufacturer Narrative
Media analysis: the device was not returned for analysis, but media was returned in the form of a photo.The photo was reviewed, which showed the alleged damage.The orientation and quality of the photo made it difficult to verify the damage in the complaint.Multiple devices were shown tangled together.

• 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: 20353830
• Report Number: 2124215-2024-61548
• Device Sequence Number: 14297464
• Product Code: KRD
• UDI-Device Identifier: 08714729983743
• UDI-Public: 08714729983743
• 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
• Report Date (Section B): 10/02/2024

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
• 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: 09/06/2024
• Initial Report FDA Received Date: 10/02/2024
• 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 Sex: Unknown