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

Model Number	M001394250080600
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Stretched (1601); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil broke, and a portion remained in the vessel.An embold soft 8x60 was selected for a procedure.During the retraction of the coil, however, resistance was felt, and the coil stretched and broke.A portion of the coil was removed, while the broken portion was left in the target vessel.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluation by manufacturer: the product was returned to boston scientific for analysis.Returned product consisted of a embold soft coil system.Visual examination: inspection of the device revealed a severely stretched and separated partial coil in multiple sections.The introducer sheath and wedge lock were not received.Perforations were intact.Microscopic examination: inspection of the device revealed a severely stretched and separated partial coil in multiple sections with both the proximal and distal couplers bent.
Event or Problem Description
It was reported that the coil broke, and a portion remained in the vessel.An embold soft 8x60 was selected for a procedure.During the retraction of the coil, however, resistance was felt, and the coil stretched and broke.A portion of the coil was removed, while the broken portion was left in the target vessel.There were no patient complications reported.

• Brand Name: EMBOLD SOFT
• 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: 20979221
• Report Number: 2124215-2024-79873
• Device Sequence Number: 18258506
• Product Code: KRD
• UDI-Device Identifier: 00191506026578
• UDI-Public: 00191506026578
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 03/05/2025

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: M001394250080600
• Device Catalogue Number: M001394250080600
• Device Lot Number: 0034247844
• 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: 12/06/2024
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown