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

Model Number	M001394260000600
Medical Device Problem Codes	Break (1069); Premature Activation (1484); Stretched (1601); Malposition of Device (2616); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Vasoconstriction (2126); Foreign Body In Patient (2687)
Date of Event	02/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results: device analysis findings: the returned device consisted of an embold packing coil without the delivery system.The coil was returned with a non-boston scientific microcatheter.The device was examined visually to reveal a stretched coil.An x-ray image revealed the coil was stretched throughout the microcatheter and the coupler was separated from the coil.The distal coupler was not returned for analysis.Device history record (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Risk review: a risk review performed for the embold device confirmed that the reported events are known events defined in the product's risk management documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of failure to follow instructions.The ifu states the embold coil is designed to be delivered with a microcatheter i.D.Of 0.021 in (0.53 mm) to 0.027 in (0.69 mm).The customer reported to use a 1.9f microcatheter with an i.D.Of 0.019in (0.48mm) during the procedure.
Event or Problem Description
It was reported that the coil snapped, and additional intervention was required, resulting in an unretrieved device fragment (udf).An embold packing 60 was selected for use to treat a persistent upper gastrointestinal (gi) bleed.The coil was used in conjunction with a 1.9f non-boston scientific microcatheter.The vessels were starting to spasm, so the coil was not taking shape and packing.The coil was attempted to be withdrawn into the microcatheter, at which point it was noted that the coil had already detached.The proximal release perforation had not been broken.The tail of the coil was observed and had to be snared out of the aorta.Approximately 15cm of the coil was left behind in the second order branch off the superior mesenteric artery (sma).The physician later explained he felt a "pop" when trying to withdraw the coil into the microcatheter.The boston scientific representative presumed that the couplers most likely were still attached and the coil instead had snapped and stretched more proximal to the couplers.There were no patient complications as a result of this event.

• 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: 24582513
• Report Number: 2124215-2026-13942
• Device Sequence Number: 13069852
• Product Code: KRD
• UDI-Device Identifier: 00191506026615
• UDI-Public: (01)00191506026615(17)280724(10)37057364
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K230706
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 03/12/2026

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: M001394260000600
• Device Catalogue Number: M001394260000600
• Device Lot Number: 0037057364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2025
• 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: 1.9F PROGREAT MICROCATHETER.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown