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

Model Number	83911
Medical Device Problem Codes	Premature Activation (1484); Difficult to Remove (1528); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil was protruding from the target aneurysm.An embold packing detachable coil system was selected for use to treat an aneurysm in the small, tortuous splenic artery.Prior to the packing coil being deployed, the physician had previously deployed two framing coils and the first packing coil.The packing coil was advanced to the aneurysm and deployed by approximately 50% when the physician realized the second packing coil would be too much.The packing coil was retracted, at which point resistance was encountered and the packing coil unintentionally deployed.A portion of the packing coil extended into the splenic artery.No corrective action was taken as a result of the protruding coil, and there were no reported patient complications.
Additional Manufacturer Narrative
Device analysis: the delivery sheath and delivery wire were returned.Visual and microscopic analysis was conducted.The delivery sheath showed no damage.The delivery wire showed no damage, and the perforations were intact.The distal and proximal couplers were attached to the delivery wire via the pull wire.The distal coupler showed a bend.The coil was separated from the distal coupler and not returned.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint was confirmed for the coil being separated and deployed unintentionally.

• Brand Name: EMBOLD PACKING 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: 18340750
• Report Number: 2124215-2023-70714
• Device Sequence Number: 17839542
• Product Code: KRD
• UDI-Device Identifier: 00191506026585
• UDI-Public: 00191506026585
• 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: 2023
• 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): 12/15/2023

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 Expiration Date: 07/02/2024
• Device Model Number: 83911
• Device Catalogue Number: 83911
• Device Lot Number: 0031940236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Male