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

Model Number	83779
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual inspection was performed.The introducer sheath, the pusher and the main coil were returned.The introducer sheath was inspected, and no damages were found.Twist lock was opened.The main coil was kinked and stretched.The pusher wire was kinked, stretched, and the interlocking arm was detached.Microscope inspection was performed.The interlocking arm of the pusher wire was detached.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2022.It was reported that the coil was stuck inside the catheter.A 4mm x 15cm interlock coil was selected for use.During the procedure, it was noted that the coil was stuck in the middle of the catheter.The coil was removed together with the catheter.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed that the interlocking arm of the pusher wire was detached.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15243901
• Report Number: 2124215-2022-29955
• Device Sequence Number: 4784999
• Product Code: KRD
• UDI-Device Identifier: 08714729764960
• UDI-Public: 08714729764960
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 08/17/2022

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: 01/03/2025
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0028802585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2022
• 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: MICRO CATHETER - 0.025INCH MEDICOS HIRATA LANTERN
• Patient Sex: Unknown