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

Model Number	83779
Medical Device Problem Codes	Break (1069); Premature Activation (1484); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name:(b)(6).E1 - initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that the coil was fractured.The target lesion was located in the bronchial artery.A 20mm x 50cm f-idc 2d coil was selected for use.During the procedure, the deployment process was not smooth, resistance was encountered during the advancement and the device was detached in the microcatheter.The device was not sent to the target position, it was pulled out with a guidewire and found fractured.The procedure was completed with another of the same device.No complications were reported and the patient was stable.
Event or Problem Description
It was reported that the coil was fractured.The target lesion was located in the bronchial artery.A 20mm x 50cm f-idc 2d coil was selected for use.During the procedure, the deployment process was not smooth, resistance was encountered during the advancement and the device was detached in the microcatheter.The device was not sent to the target position, it was pulled out with a guidewire and found fractured.The procedure was completed with another of the same device.No complications were reported and the patient was stable.It was further reported that the coil was released in the microcatheter and the fractured part was not known.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital.E1 - initial reporter address 1: (b)(6).Correction from h6 - device code: a0401 break to a150103 premature activation.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital e1 - initial reporter address 1: (b)(6).Correction from h6 - device code: a0401 break to a150103 premature activation device evaluated by mfr.: the device was returned for analysis.Visual inspection shows the main coil, the pusher wire and the introducer sheath were returned for the analysis.The main coil was bent and stretched at the middle section and the pusher wire was bent at the distal section.The pouch was returned, and it was observed that the pouch information matches with the complaint information.No more damages were observed.The functional inspection could not be performed due the coil and the pusher are not interlocking.The coil arm outer diameter (od), zap tip maximum od and primary coil od were measured and found to be within specification.
Event or Problem Description
It was reported that the coil was fractured.The target lesion was located in the bronchial artery.A 20mm x 50cm f-idc 2d coil was selected for use.During the procedure, the deployment process was not smooth, resistance was encountered during the advancement and the device was detached in the microcatheter.The device was not sent to the target position, it was pulled out with a guidewire and found fractured.The procedure was completed with another of the same device.No complications were reported, and the patient was stable.It was further reported that the coil was released in the microcatheter, and the fractured part was not known.

• 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: 17612535
• Report Number: 2124215-2023-45646
• Device Sequence Number: 20682479
• Product Code: KRD
• UDI-Device Identifier: 08714729845317
• UDI-Public: 08714729845317
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2023

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: 05/30/2025
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0029689148
• 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: 08/03/2023
• Supplement Date Received by Manufacturer: 08/24/2023; 10/25/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 09/06/2023; 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2022
• 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
• Patient Age: 15 YR
• Patient Sex: Male
• Patient Weight: 48 KG