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

Model Number	M001394260000450
Medical Device Problem Codes	Difficult to Insert (1316); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device analysis: the product was returned to boston scientific for analysis.Returned product consisted of a embold packing coil system.Visual inspection of the device revealed a stretched and detached coil.There was no introducer sheath damage, and the perforations were intact.Microscopic inspection of the device revealed a severely stretched and detached coil from the distal coupler weld and no coupler damage.Media was returned in the form of a photo.The photo was reviewed which showed the embold introducer sheath inside the hub of a non-bsc device with no relevant information pertaining to the investigation.
Event or Problem Description
Reportable based on device analysis completed on 10jan2025.An embold packing 45 coil was selected for use.The physician had delivered a combination of embold fibered, soft, and packing coils via a non-boston scientific microcatheter without difficulty.There was a difficult branch to engage with the first microcatheter, so the device was exchanged for a shorter non-boston scientific microcatheter.Once the vessel was engaged, the physician wanted to deploy an embold packing coil.The physician met resistance when trying to advance the coil into the microcatheter and noticed the distal tip of the coil was kinked.The coil was removed and not implanted.The physician asked for a second embold packing coil and had some difficulty advancing again but was able to get the coil within the microcatheter.However, with the increased resistance with advancing the coil, the physician decided to remove the second coil.Upon retracting the coil, the coil began to stretch.The entire coil was removed from the microcatheter.At this point, the physician decided to stop the case and reevaluate the images.The physician then realized what was needed to be done was accomplished and the procedure was ended.The microcatheter and base catheter were removed.No patient complications occurred.However, device analysis revealed the coil had detached from the coupler weld.

• 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: 21314904
• Report Number: 2124215-2025-06143
• Device Sequence Number: 8848931
• 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): 02/05/2025

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: 0034535812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER: PROGREAT 2.4FR X130CM; CATHETER: SWIFT NINJA 2.4FR X125CM
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Race: White