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

Model Number	83779
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name:(b)(6).Device evaluated by mfr: the complaint device was received for product analysis.The main coil, the pusher wire and the introducer sheath were returned for this complaint.And it was observed that the main coil was stretched and detached at interlocking arm section.Also, the pusher wire was stretched, and the interlocking arm was detached.The detached sections were not returned.The twist lock was opened.Blood was noticed inside the introducer sheath.Microscopic inspection of the device was performed and revealed that the interlocking arm of the main coil was detached.Also, the interlocking arm of the pusher wire was detached.The functional test could not be performed since the arms of the pusher wire and the main coil were detached.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 31jan2023.It was reported that the coil could not be advanced from the catheter.A 22mm x 60cm interlock coil was selected for use in the aorta abdominalis.During the procedure, it was noted that the coil could not push out from the catheter cavity even after several attempts due to obvious resistance during the conveying process.The coil was simply pulled out from the patient's body and the procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.However, device analysis revealed that the main coil was detached at interlocking arm section and the interlocking arm of the pusher wire 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: 16404785
• Report Number: 2124215-2023-07233
• Device Sequence Number: 3327765
• Product Code: KRD
• UDI-Device Identifier: 08714729845324
• UDI-Public: 08714729845324
• 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): 02/20/2023

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: 01/03/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0026736007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2021
• 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
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 80 KG