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

Model Number	83779
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).Initial reporter address 1: (b)(6).
Event or Problem Description
It was reported, that the procedure was cancelled/rescheduled.The target lesion was located in the coronary arterio-pulmonary artery fistula.A 6mm x 20cm pe f-idc coil was selected for use.During the procedure, it was noted, that the coil could not be released when advanced out of the microcatheter.The physician made multiple attempts.However, the device still could not be released.And had to be withdrawn from the patient.The procedure was rescheduled three days later.And was completed successfully with device released.There were no patient complications reported.And the patient was stable.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).E1 - initial reporter address (b)(6).Device evaluated by mfr: the device was returned for analysis.Only the main coil was retuned for the analysis.It is possible observed the main coil kinked in the middle section.The pouch was returned, and it was observed that the pouch information matches with the complaint information.No more damages were observed.The functional inspection could not be performed, because only the main coil was returned.
Event or Problem Description
It was reported that the procedure was cancelled/rescheduled.The target lesion was located in the coronary arterio-pulmonary artery fistula.A 6mm x 20cm pe f-idc coil was selected for use.During the procedure, it was noted that the coil could not be released when advanced out of the microcatheter.The physician made multiple attempts however, the device still could not be released and had to be withdrawn from the patient.The procedure was rescheduled three days later and was completed successfully with device released.There were no patient complications reported and the patient 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: 17100392
• Report Number: 2124215-2023-27284
• Device Sequence Number: 11258482
• Product Code: KRD
• UDI-Device Identifier: 08714729765004
• UDI-Public: 08714729765004
• 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
• Report Date (Section B): 07/20/2023

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: 11/12/2025
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0030701912
• 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: 05/22/2023
• Supplement Date Received by Manufacturer: 07/01/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2022
• 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
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 60 KG