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

Model Number	83779
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	06/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 15aug2023.It was reported that the coil was stuck inside the catheter.An 8mm x 20cm 2d interlock coil was selected for embolization of splenic aneurysm.During the procedure, a non-boston scientific microcatheter was used to deploy four bsc coils.However, when the third one was being deployed, it was noted that the coil was stuck inside the catheter.After removal of the device, the procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.However, device analysis revealed that the main coil was detached at the coil arm section.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.Visual inspection was performed, and it was revealed that the main coil and the pusher wire were returned inside the introducer sheath; it was necessary to make cuts to free the main coil.It was observed that the main coil was stretched, bent and detached at the coil arm section and it was observed bent and stretched at the zap tip section.No more damages were observed during visual inspection.Under the microscope it was observed that the main coil was stretched, bent and detached at the coil arm section and it was observed bent and stretched at the zap tip section.The functional inspection could not be performed, because the pusher wire and the main coil 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 ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17695907
• Report Number: 2124215-2023-46184
• Device Sequence Number: 16794025
• Product Code: KRD
• UDI-Device Identifier: 08714729765011
• UDI-Public: 08714729765011
• 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
• Report Date (Section B): 09/06/2023

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: 08/15/2025
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0030154334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 09/06/2023
• 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
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 52 KG