MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83787
Medical Device Problem Codes	Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr: the main coil and the introducer sheath were returned for analysis.A visual and microscopic inspection were performed, and it was observed that the main coil was bent, stretched and detached at the coil arm and zap tip section.Additionally, the introducer sheath was detached.Analysis was unable to confirm the allegation of unable to advance in the catheter.The issues found during analysis could be related to excessive handling of the device and the technique used during the procedure.
Event or Problem Description
Reportable based on the device analysis completed on 19sep2024.It was reported that the coil could not be advance in the lesion.The target lesion was located in the splenic artery about 2cm in diameter.A 20mm x 40cm interlock.035 coil was selected for use.However, during the procedure, it was noted that the coil could not be fully advanced into the target aneurysm.Multiple attempts were made to recapture and redeploy the coil, but it became stuck in the single curve and could not be fully pushed out to unlock the interlock arm.Eventually, the procedure was completed using a boston scientific (bsc) 18 stc microcatheter, along with 12mm30cm and 8mm*20cm bsc coils.No patient complications were reported, and the patient was stable post-procedure.However, device analysis revealed main coil detachment at the coil arm and zap tip section.

• Brand Name: INTERLOCK-35
• 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: 20444847
• Report Number: 2124215-2024-63516
• Device Sequence Number: 20874402
• Product Code: KRD
• UDI-Device Identifier: 08714729795445
• UDI-Public: 08714729795445
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133208
• 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
• Report Date (Section B): 10/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2025
• Device Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0030144861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2022
• 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
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 70 KG