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

Model Number	83777
Medical Device Problem Codes	Component Missing (2306); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that there was no fibered coil.The target lesion was located in the splenic artery.A 2/3mm x 2.3cm f-idc vortx diamond interlock coil was selected for use.During the procedure, the coil failed to form inside the lesion when the physician tried to deploy it.The coil was withdrawn and another attempt to deploy was unsuccessful as the coil still failed to form.Consequently, it was withdrawn for the second time and deployed outside the patient, and found there was "no fibered coil".The physician noted, "after end has interlocking arm the front has nothing".Confirmation was made no device fragments were left inside the patient.The procedure was completed by unknown injected embolic microspheres.There were no complications reported and the patient was stable post-procedure.
Event or Problem Description
It was reported that there was no fibered coil.The target lesion was located in the splenic artery.A 2/3mm x 2.3cm f-idc vortx diamond interlock coil was selected for use.During the procedure, the coil failed to form inside the lesion when the physician tried to deploy it.The coil was withdrawn and another attempt to deploy was unsuccessful as the coil still failed to form.Consequently, it was withdrawn for the second time and deployed outside the patient, and found there was "no fibered coil".The physician noted, "after end has interlocking arm the front has nothing".Confirmation was made no device fragments were left inside the patient.The procedure was completed by unknown injected embolic microspheres.There were no complications reported and the patient was stable post-procedure.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.Device evaluated by manufacturer: the device was returned for analysis.The pusher wire and the introducer sheath were returned.The main coil was not returned.The twist lock of the introducer sheath was found opened.The introducer sheath was inspected, and no anomalies were noted.Blood was noticed inside the introducer sheath.The pusher wire was inspected, and it was broken, kinked and stretched.The proximal end of the pusher wire had a smooth surface.The interlocking arm was inspected, and no anomalies were noted.The dimensional inspection revealed that the outer diameter (od) at the solder joint and tfe were found to be within specification.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13590975
• Report Number: 2134265-2022-02052
• Device Sequence Number: 4018863
• Product Code: KRD
• UDI-Device Identifier: 08714729765080
• UDI-Public: 08714729765080
• 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): 04/01/2022

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: 05/03/2024
• Device Model Number: 83777
• Device Catalogue Number: 83777
• Device Lot Number: 0027428993
• 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: 01/26/2022
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2021
• 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 Sex: Unknown