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

Model Number	83779
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the delivery wire fractured.An 8mm x 20cm interlock was selected for embolization of a renal artery aneurysm.During the procedure, the coil was advanced, but the delivery wire fractured, and the tip of the coil was deformed when pulled out.After another one of the same models was used, it was successfully delivered.Subsequently, 6x20 and 5x15 were used successively for tamponade, which was satisfactory after angiography.Then the angiography catheter was used to superselect another tumor.10x40 interlock-35 was used for tamponade first, and then two 8x20.After the image was shown, it was almost satisfactory.Finally, catheter was selected into tumor cavity and 4x15 interlock-18 was used for final tamponade, and the procedure was completed.No complications reported, and patient was stable following the procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The main coil, the pusher wire and the introducer sheath returned for the analysis.It is possible to observe the main coil was stretched and kinked.Additionally, the pusher wire was bent.The pouch was returned, and it was observed that the pouch information matches with the complaint information.Under the microscope, it was observed the main coil was stretched and kinked.The functional inspection could not be performed because the main coil and the pusher wire are not interlocking.Dimensional inspection of the main coil that could be measured was performed and were within specification.
Event or Problem Description
It was reported that the delivery wire fractured.An 8mm x 20cm interlock was selected for embolization of a renal artery aneurysm.During the procedure, the coil was advanced, but the delivery wire fractured, and the tip of the coil was deformed when pulled out.After another one of the same models was used, it was successfully delivered.Subsequently, 6x20 and 5x15 were used successively for tamponade, which was satisfactory after angiography.Then the angiography catheter was used to superselect another tumor.10x40 interlock-35 was used for tamponade first, and then two 8x20.After the image was shown, it was almost satisfactory.Finally, catheter was selected into tumor cavity and 4x15 interlock-18 was used for final tamponade, and the procedure was completed.No complications reported, and patient was stable following the procedure.

• 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: 17039323
• Report Number: 2124215-2023-26229
• Device Sequence Number: 6515919
• 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,Followup
• Report Date (Section B): 07/07/2023

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: 10/16/2025
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0030548989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/06/2023
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 48 KG