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

Model Number	M001394260000450
Medical Device Problem Codes	Break (1069); Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation by manufacturer: the returned device consists of embold packing coil.A 5 french imager was received with the device.Visual examination of the returned imager revealed no damage detected.Visual examination revealed the coil was snared from the imager.The snare, coil, touy, torque device and imager were received all connected.Embold coil is stretched.The microcatheter was removed and not returned.Microscopic examination revealed the coil coupler is detached.Product analysis confirmed the reported event of coil stretch and break.
Event or Problem Description
It was reported that the coil broke and required a snare for retrieval.An embold packing 45 was selected for a hypo embolization procedure in the mildly tortuous internal iliac artery.While advancing the coil using intermittent flushing, it became difficult to push from the distal part of the 2.4 french non-boston scientific microcatheter.It was attempted to retract the coil, but the coil stretched to the point of breaking.The coil broke off with a portion in the catheter and a portion in the coil nest.The microcatheter was removed with one fractured portion of the coil inside, and the fractured portion in the coil nest was removed with a snare.No coil was left in the patient.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Correction: b1 adverse event/product problem selected.Device evaluation by manufacturer: the returned device consists of embold packing coil.A 5 french imager was received with the device.Visual examination of the returned imager revealed no damage detected.Visual examination revealed the coil was snared from the imager.The snare, coil, touy, torque device and imager were received all connected.Embold coil is stretched.The microcatheter was removed and not returned.Microscopic examination revealed the coil coupler is detached.Product analysis confirmed the reported event of coil stretch and break.
Event or Problem Description
It was reported that the coil broke and required a snare for retrieval.An embold packing 45 was selected for a hypo embolization procedure in the mildly tortuous internal iliac artery.While advancing the coil using intermittent flushing, it became difficult to push from the distal part of the 2.4 french non-boston scientific microcatheter.It was attempted to retract the coil, but the coil stretched to the point of breaking.The coil broke off with a portion in the catheter and a portion in the coil nest.The microcatheter was removed with one fractured portion of the coil inside, and the fractured portion in the coil nest was removed with a snare.No coil was left in the patient.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: 21713059
• Report Number: 2124215-2025-16691
• Device Sequence Number: 4745447
• Product Code: KRD
• UDI-Device Identifier: 00191506026608
• UDI-Public: (01)00191506026608(17)270917(10)34866419
• 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): 04/01/2025

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: M001394260000450
• Device Catalogue Number: M001394260000450
• Device Lot Number: 0034866419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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: Required Intervention
• Patient Sex: Unknown