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

Model Number	83779
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.Visual inspection revealed that the main coil, the pusher wire, the introducer sheath and the rotating hemostatic valve (rhv) were returned for this complaint.The main coil and the pusher wire were not interlocked.Blood was noticed inside the introducer sheath.The twist lock was opened.The main coil was stretched and detached at interlocking arm section.No more damages were observed.The functional test could not be performed since the main coil and the pusher wire were not interlocked.Under microscope it was observed that the interlocking arm of the main coil was detached.Dimensional inspection of the pusher wire and main coil revealed the components were within specifications.
Event or Problem Description
Reportable based on device analysis completed on 11jan2023.It was reported that the coil could not reach the lesion.A 12mmx30cm interlock was selected for use in the embolization of a renal aneurysm.During the procedure, a 2.4f microcatheter was used, and the first coil deployed smoothly.While positioning the second coil, it was found that the position was not ideal, so the coil was withdrawn into the protective sheath.After adjusting the position, it was found that the coil could not be pushed normally in the microcatheter.The coil could not reach the lesion.The coil was withdrawn.The procedure was completed with another of the same device.No patient complications were reported, and the patient was stable post procedure.However, device analysis revealed that the interlocking arm was detached.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16306571
• Report Number: 2124215-2023-02580
• Device Sequence Number: 6075231
• Product Code: KRD
• UDI-Device Identifier: 08714729765059
• UDI-Public: 08714729765059
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/06/2023

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: 09/06/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0028164270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2021
• 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: DELIVERY CATHETER, STC18 MICROCATHETER
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 60 KG