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

Model Number	83779
Medical Device Problem Codes	Entrapment of Device (1212); Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that coil detachment occurred requiring snaring for removal.A 6mm x 20cm interlock coil was selected for embolization of hepatic artery.During the procedure, right hepatic embolization was planned for the patient, but the coil went to gastroduodenal artery (gda).Resheathing was done inside the microcatheter, but the coil has detached inside the microcatheter from delivery wire.Snare was used to remove the coil from gda, as 95% of the coil was in patient body and only 5% was in the microcatheter.The procedure was completed using an alternate device and no patient complications reported.
Event or Problem Description
It was reported that coil detachment occurred requiring snaring for removal.A 6mm x 20cm interlock coil was selected for embolization of hepatic artery.During the procedure, right hepatic embolization was planned for the patient, but the coil went to gastroduodenal artery (gda).Resheathing was done inside the microcatheter, but the coil has detached inside the microcatheter from delivery wire.Snare was used to remove the coil from gda, as 95% of the coil was in patient body and only 5% was in the microcatheter.The procedure was completed using an alternate device and no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.A visual inspection was performed, and it was observed that the main coil, the introducer sheath, the pusher wire and rhv were returned.It was observed that the main coil was bent/kinked and stretched at the primary coil and zap tip section.A part of the original pouch was returned, and it was observed that the pouch information matches with the complaint information.No more damages were observed during visual inspection.The functional could not be performed due the main coil and the pusher wire are not interlocking.Dimensional inspection of the main coil revealed the components were within specifications.No other issues were identified during the product analysis.

• Brand Name: INTERLOCK
• 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 CORK LIMITED; 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: 17460227
• Report Number: 2124215-2023-39233
• Device Sequence Number: 7189716
• Product Code: KRD
• UDI-Device Identifier: 08714729765004
• UDI-Public: 08714729765004
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2024

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 Expiration Date: 08/15/2025
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0030154331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2022
• 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 Age: 30 YR
• Patient Sex: Female
• Patient Race: Asian