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

Model Number 83779

Device Problem Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.The main coil, the pusher wire and an introducer sheath returned for the analysis, and it was observed that the main coil was bent middle section and stretched and bent at the coil arm section.Additionally, it is possible observed presence of blood inside the introducer.No more damages were observed.Under the microscope it was observed that the main coil was stretched, bent and detached at the middle section, and stretched and bent at the coil arm section.The functional inspection could not be performed, because the delivery wire and the main coil are not interlocking.Dimensional inspection of the main coil revealed that the coil arm, zap tip and primary coil outer diameter met specification.

Event Description

Reportable based on device analysis completed on (b)(6) 2023.It was reported that the coil was stuck inside the microcatheter.The target lesion was located in the spleen.A 14mm x 30cm interlock was selected for embolization.During the procedure, when the device was advanced to the tail end of the coil, it was noted that the coil was stuck inside the microcatheter.In order to ensure the successful completion of the procedure, a new microcatheter and a new coil of the same model were used to continue the procedure.The device was successfully deployed and the procedure was successfully completed.No complications were reported and the patient was stable post procedure.However, device analysis revealed that the main coil was detached at the middle section.

Manufacturer Narrative

Corrected - device evaluated by mfr: the device was returned for analysis.The main coil, the pusher wire and an introducer sheath returned for the analysis, and it was observed that the main coil was bent middle section and stretched and bent at the coil arm section.Additionally, it is possible observed presence of blood inside the introducer.No more damages were observed.Under the microscope it was observed that the main coil was stretched and bent at the middle section and stretched and bent at the coil arm section.The functional inspection could not be performed, because the delivery wire and the main coil are not interlocking.Dimensional inspection of the main coil revealed that the coil arm, zap tip and primary coil outer diameter met specification.Device evaluated by mfr: the device was returned for analysis.The main coil, the pusher wire and an introducer sheath returned for the analysis, and it was observed that the main coil was bent middle section and stretched and bent at the coil arm section.Additionally, it is possible observed presence of blood inside the introducer.No more damages were observed.Under the microscope it was observed that the main coil was stretched, bent and detached at the middle section, and stretched and bent at the coil arm section.The functional inspection could not be performed, because the delivery wire and the main coil are not interlocking.Dimensional inspection of the main coil revealed that the coil arm, zap tip and primary coil outer diameter met specification.

Event Description

Reportable based on device analysis completed on (b)(6) 2023.It was reported that the coil was stuck inside the microcatheter.The target lesion was located in the spleen.A 14mm x 30cm interlock was selected for embolization.During the procedure, when the device was advanced to the tail end of the coil, it was noted that the coil was stuck inside the microcatheter.In order to ensure the successful completion of the procedure, a new microcatheter and a new coil of the same model were used to continue the procedure.The device was successfully deployed and the procedure was successfully completed.No complications were reported and the patient was stable post procedure.However, device analysis revealed that the main coil was detached at the middle section.

• Brand Name: INTERLOCK
• Type of Device: 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: 17482451
• MDR Text Key: 321309405
• Report Number: 2124215-2023-41603
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729765073
• UDI-Public: 08714729765073
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K132578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/31/2023

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
• Device Operator: Health Professional
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0030820813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2023
• Initial Date FDA Received: 08/08/2023
• Supplement Dates Manufacturer Received: 08/10/2023
• Supplement Dates FDA Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 65 KG