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

Model Number	M001394260000450
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a coil break occurred.An embold packing coil was selected for use in a bilateral renal artery embolization procedure.The vessel was mildly tortuous.After implanting a fibered coil with no issue, the embold packing coil was delivered with a pulsation method.It was noted that the coil was not advancing and the coil became detached into two pieces.During an attempt to pull the coil back, it maintained inside the 2.4 french non-boston scientific microcatheter.Several wires were used to push the coil forward and a wire was placed along side of the coil and anchored it against the micro catheter.Everything was able to be retrieved.The procedure was completed with another base and micro catheter.There were no patient complications and the patient status was stable.

• Brand Name: EMBOLD PACKING
• 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: 20866255
• Report Number: 2124215-2024-76482
• Device Sequence Number: 8838506
• Product Code: KRD
• UDI-Device Identifier: 00191506026608
• UDI-Public: 00191506026608
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K230706
• 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): 12/06/2024

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 Model Number: M001394260000450
• Device Catalogue Number: M001394260000450
• Device Lot Number: 0033460209
• 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: 11/13/2024
• Initial Report FDA Received Date: 12/06/2024
• Date Device Manufactured: 02/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER: 2.8 PROGREAT OMEGA AND C2
• Patient Age: 80 YR
• Patient Sex: Male