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	11/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address 1- (b)(6).Device evaluated by mfr: the complaint device was received for product analysis.A visual examination identified that the main coil was returned stuck in the tip of a non-bsc catheter, also the rotating hemostatic valve and the pusher wire were returned for this complaint.Blood was noticed above the pusher wire and the main coil.The main coil was stretched, kinked and the interlocking arm detached.The pusher wire was kinked/bent at several parts.The functional test could not be performed due the returned condition of the device due the device returned incomplete.Microscope inspection revealed that the interlocking arm of the main coil was detached.Dimensional inspection of the pusher wire that could be measured were performed and were within specifications.Dimensional inspection of the main coil that could be measured were performed and revealed that the outer diameter (od) of the zap tip and primary coil were within specification, however the od of the coil arm could not be measured due the interlocking arm of the main coil was detached.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2022.It was reported that the coil was stuck and stretched when it was withdrawn.The target lesion was located in the aorta abdominalis.An 8mm x 20cm interlock was selected for use.During the procedure, after the microcatheter and guidewire were used to superselect the distal end in place, the eighth coil was positioned.However, it got stuck and could not forward or backward.Subsequently, the coil was withdrawn with the microcatheter out of the patient's body.It was further noted that the coil was stuck in the export of the microcatheter, which stretched seriously.The procedure was completed with another of the same device.No patient complications were reported.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: 16114086
• Report Number: 2124215-2022-55854
• Device Sequence Number: 6839120
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/06/2023

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: 07/04/2025
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0029889968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE- FATHOM; MICROCATHETER- STC 18
• Patient Age: 58 YR
• Patient Sex: Male