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

Model Number	83779
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920); Material Integrity Problem (2978); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that coil migration occurred and was removed by guidewire.A 10mm x 30cm interlock was selected for use in a splenic artery aneurysm.During the procedure, when the coil was advanced with the stc18 microcatheter, something wrong was found in the process of delivery.It was very dry and not smooth.When the coil has been advanced halfway inside the patient, it was found that the microcatheter moved to another position.During withdrawal, it was found that it could not be withdrawn to the sheath.All the coils had to be withdrawn, which fell off.The coil was just could not fully retract, not broken.The coil was removed by the guidewire and the procedure was completed with another of the same device.No complications were reported and patient was stable post procedure.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that coil migration occurred and was removed by guidewire.A 10mm x 30cm interlock was selected for use in a splenic artery aneurysm.During the procedure, when the coil was advanced with the stc18 microcatheter, something wrong was found in the process of delivery.It was very dry and not smooth.When the coil has been advanced halfway inside the patient, it was found that the microcatheter moved to another position.During withdrawal, it was found that it could not be withdrawn to the sheath.All the coils had to be withdrawn, which fell off.The coil was just could not fully retract, not broken.The coil was removed by the guidewire and the procedure was completed with another of the same device.No complications were reported and patient was stable post procedure.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).Device evaluated by mfr: only the pusher wire returned for the analysis.Visual inspection revealed that the pusher wire was bent.No more damages were observed during the analysis.The functional inspection could not be performed, because only the delivery wire was returned.No other issues were identified during the product analysis.

• 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: 17198015
• Report Number: 2124215-2023-31687
• Device Sequence Number: 5683902
• Product Code: KRD
• UDI-Device Identifier: 08714729765035
• UDI-Public: 08714729765035
• 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,Followup
• Report Date (Section B): 08/11/2023

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: 10/01/2025
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0030458594
• 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: 06/12/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female