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

Model Number	83779
Medical Device Problem Codes	Failure to Advance (2524); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).Device evaluated by manufacturer: the main coil, the introducer sheath and pusher wire were returned for the analysis.Visual and microscopic inspection revealed that the main coil was stretched and bent at the zap tip, coil arm and middle section.Additionally, the main coil was detached at the middle section.No more damages were observed.The functional inspection could not be performed, because the main coil and the pusher wire are not interlocking.The dimensional inspection revealed that the outer diameter (od) at the zap tip and primary coil were found to be within specification.
Event or Problem Description
Reportable based on device analysis completed on 09oct2023.It was reported that the coil was unable to advance in the catheter and damage occurred.The target lesion was located in the intrahepatic portal vein.A 6mm x 20cm interlock was selected for use.During the transjugular intrahepatic portosystemic shunt (tips) procedure, a 0.020 non-boston scientific microcatheter was used to deploy 5 coils.The second coil was delivered approximately 5cm out from the catheter and during deployment in the shunt, it was noted that the coil was stuck in the middle of the catheter.The coil could be pulled back but could not be advanced forward.Despite multiple attempts, it could not be delivered.After removal of the coil, it was noted that the interlock was damaged.The procedure was completed with another of the same device.There were no complications reported and the patient was stable post procedure.However, device analysis revealed that the main coil was detached.

• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18030973
• Report Number: 2124215-2023-58567
• Device Sequence Number: 6060209
• Product Code: KRD
• UDI-Device Identifier: 08714729765004
• UDI-Public: 08714729765004
• 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): 10/30/2023

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: 05/11/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0027474319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2021
• 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: 0.020 COOK MICROCATHETER
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 70 KG