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

Model Number	83779
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil was stuck.The target lesion was located in the splenic artery.A 22mm x 60cm f-idc 2d interlock coil was selected for use.During the procedure, the coil was not positioned satisfactorily when released.The device was retracted and reposition, however, half of the coil got stuck in the microcatheter and could not be retracted, and then the physician tried several times but still could not be retracted.The saline was flushed and other methods were performed but still could be resolved.The coil was stretched inside the patient's body and the physician referred the patient for open procedure.There were no patient complications reported.
Event or Problem Description
It was reported that the coil was stuck.The target lesion was located in the splenic artery.A 22mm x 60cm f-idc 2d interlock coil was selected for use.During the procedure, the coil was not positioned satisfactorily when released.The device was retracted and reposition, however, half of the coil got stuck in the microcatheter and could not be retracted, and then the physician tried several times but still could not be retracted.The saline was flushed and other methods were performed but still could be resolved.The coil was stretched inside the patient's body and the physician referred the patient for open procedure.There were no patient complications reported.It was further reported that the microcatheter used was stc18 and a splenic artery resection was performed to remove the coil.The patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: upon receipt, it was noted that only the main coil was returned for analysis.Visual inspection revealed that the main coil was stretched, bent and detached at the zap tip section and at the coil arm section.No more damages were observed.Microscopic inspection confirmed that the main coil was stretched, bent, and detached at the zap tip section and at the coil arm section.No further inspection could be performed because only the main coil was returned.The clinical observations were confirmed due to the condition of the device.
Event or Problem Description
It was reported that the coil was stuck.The target lesion was located in the splenic artery.A 22mm x 60cm f-idc 2d interlock coil was selected for use.During the procedure, the coil was not positioned satisfactorily when released.The device was retracted and reposition, however, half of the coil got stuck in the microcatheter and could not be retracted, and then the physician tried several times but still could not be retracted.The saline was flushed and other methods were performed but still could be resolved.The coil was stretched inside the patient's body and the physician referred the patient for open procedure.There were no patient complications reported.It was further reported that the microcatheter used was stc18 and a splenic artery resection was performed to remove the coil.The patient status was stable.

• 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: 17210162
• Report Number: 2124215-2023-33253
• Device Sequence Number: 5440600
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/19/2025
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0030383266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 06/30/2023; 08/10/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 07/24/2023; 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2022
• 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: MICROCATHETER: STC18; MICROCATHETER: STC18
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 68 KG