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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1- initial reporter facility name: (b)(6) hospital.
Event or Problem Description
It was reported that the coil was detached.The target lesion was located in the digestive tract area.A 3mm x 6cm interlock coil was selected for use.The device was continuously flushed before introduction of the coil.During the procedure, one 4 x 12 and one 4 x 8 boston scientific controllable coils were placed successfully.During the placement of the last 3mm x 6cm interlock coil, it was noted that the coil and the interlocking arm were dislodged.The coil and the catheter were removed together.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.
Additional Manufacturer Narrative
Updated f10/h6: device code.E1- initial reporter facility name: (b)(6) hospital.Device evaluated by manufacturer: the device was returned for analysis.Visual inspection was performed on the pusher wire and the introducer sheath, and it was observed that the pusher wire was kinked at the distal and middle section.The introducer was kinked at the proximal section.No more damages were observed on the device.The functional inspection could not be performed due to the main coil was not returned for the analysis.
Event or Problem Description
It was reported that the coil was detached.The target lesion was located in the digestive tract area.A 3mm x 6cm interlock coil was selected for use.The device was continuously flushed before introduction of the coil.During the procedure, one 4 x 12 and one 4 x 8 boston scientific controllable coils were placed successfully.During the placement of the last 3mm x 6cm interlock coil, it was noted that the coil and the interlocking arm were dislodged.The coil and the catheter were removed together.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.It was further reported that the interlocking arm was not intact on the coil upon removal from the patient.A fluoroscopy was done to confirmed that the coil was completely removed from the patient and that the coil was dislodge inside the microcatheter.
Additional Manufacturer Narrative
E1- initial reporter facility name: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.Visual inspection was performed on the pusher wire and the introducer sheath were returned for the analysis, and it was observed that the pusher wire was kinked at the distal and middle section.The introducer was kinked at the proximal section.No more damages were observed on the device.The functional inspection could not be performed due the main coil was not returned for the analysis.
Event or Problem Description
It was reported that the coil was detached.The target lesion was located in the digestive tract area.A 3mm x 6cm interlock coil was selected for use.The device was continuously flushed before introduction of the coil.During the procedure, one 4 x 12 and one 4 x 8 boston scientific controllable coils were placed successfully.During the placement of the last 3mm x 6cm interlock coil, it was noted that the coil and the interlocking arm were dislodged.The coil and the catheter were removed together.The procedure was completed with another of same device.No complications were reported, and patient was stable post 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17785201
• Report Number: 2124215-2023-49564
• Device Sequence Number: 6876344
• Product Code: KRD
• UDI-Device Identifier: 08714729764939
• UDI-Public: 08714729764939
• 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,Followup
• Report Date (Section B): 12/18/2023

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: 06/11/2025
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0029748260
• 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: 08/29/2023
• Supplement Date Received by Manufacturer: 11/02/2023; 11/21/2023
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 11/16/2023; 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2022
• 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: CATHETER: CORDIS 5FR.; CATHETER: CORDIS 5FR.; CATHETER: CORDIS 5FR.
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 51 KG