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

Model Number	83779
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device evaluated by manufacturer: the device was returned for analysis.A non-boston scientific catheter and the main coil were returned.The main coil was outside the catheter.The main coil was stretched, and the interlocking arm was detached.Functional testing could not be performed since the device was returned incomplete.Microscopic inspection confirmed that the interlocking arm of the main coil was detached.
Event or Problem Description
Reportable based on device investigations completed on 20jan2023.It was reported that the coil was stuck in the catheter.A 10mm x 30cm pe f-idc interlock was selected for use in the embolization of a splenic aneurysm.During the procedure when this device was deployed, it was noted that the coil could not be advanced in 1/3 of the deploying process.The physician tried for several times to advance the coil slowly but failed.In addition, the coil could not be withdrawn.The device was slowly withdrawn together with the microcatheter.After the procedure, the coil and the microcatheter were checked, which revealed that the coil had been stuck in the middle of the catheter.Later, the coil was taken out, which was found to be stretched.There were no patient complications reported, and the patient is stable.However, device investigations revealed that the interlocking arm of the main coil 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: 16380481
• Report Number: 2124215-2023-03184
• Device Sequence Number: 5898479
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/15/2023

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: 07/13/2023
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0025851389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2020
• 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-BSC STC-18
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 58 KG