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

Model Number	83779
Medical Device Problem Codes	Premature Activation (1484); Stretched (1601); Separation Failure (2547); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that an intervention was performed to remove the coil.The target lesion was located in the splenic artery aneurysm.A 10mm x 30cm 2d interlock coil was advanced for treatment.During the procedure, the coil was flushed and delivered using an stc 18 microcatheter.When the coil was delivered, it could not be release, and it was stretched.The coil could not be withdrawn with the catheter, so the physician removed the catheter first and then used a snare to remove the spring coil.No complications were reported, and the patient was stable.
Additional Manufacturer Narrative
E1 initial reporter facility name:(b)(6) hospital.
Event or Problem Description
It was reported that an intervention was performed to remove the coil.The target lesion was located in the splenic artery aneurysm.A 10mm x 30cm 2d interlock coil was advanced for treatment.During the procedure, the coil was flushed and delivered using an stc 18 microcatheter.When the coil was delivered, it could not be release, and it was stretched.The coil could not be withdrawn with the catheter, so the physician removed the catheter first and then used a snare to remove the spring coil.No complications were reported, and the patient was stable.It was further reported that the lesion was moderately tortuous and non-calcified artery.The coil was detached inside the microcatheter, which could not be advanced or withdrawn.
Additional Manufacturer Narrative
E1 initial reporter facility name: (b)(6) hospital.Device evaluated by mfr.: the device was returned for analysis.Visual inspection observed that only the main coil was returned.It was also observed that the main coil was bent and stretched at the coil arm and primary coil section.Microscopic inspection of the main coil was bent and stretched.The functional could not be performed due the main coil and the pusher wire are not interlocking.
Event or Problem Description
It was reported that an intervention was performed to remove the coil.The target lesion was located in the splenic artery aneurysm.A 10mm x 30cm 2d interlock coil was advanced for treatment.During the procedure, the coil was flushed and delivered using an stc 18 microcatheter.When the coil was delivered, it could not be release, and it was stretched.The coil could not be withdrawn with the catheter, so the physician removed the catheter first and then used a snare to remove the spring coil.No complications were reported, and the patient was stable.It was further reported that the lesion was moderately tortuous and non-calcified artery.The coil was detached inside the microcatheter, which could not be advanced or withdrawn.

• 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 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: 19987950
• Report Number: 2124215-2024-49742
• Device Sequence Number: 7001668
• Product Code: KRD
• UDI-Device Identifier: 08714729765035
• UDI-Public: 08714729765035
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 09/26/2024

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: 08/15/2026
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0032435600
• 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: 07/30/2024
• Supplement Date Received by Manufacturer: 08/19/2024; 09/26/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 09/10/2024; 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2023
• 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: MICROCATHETER: STC18; MICROCATHETER: STC18; MICROCATHETER: STC18
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Male