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

Model Number	83779
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil protruded from the catheter's tip during removal.The non-stenosed target lesion was located in the severely tortuous and non-calcified splenic artery.A 22mm x 60cm interlock coil was selected for use.During the procedure, the coil became stuck in the distal part of the catheter.When the coil was removed from the patient's body, it was noted that the coil protruded from the tip of the microcatheter.Only the coil was removed and the procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
(b)(6).
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).Device evaluated by mfr: the device was returned for evaluation.The device returned with a main coil, pusher wire, and introducer sheath.Visual inspection was performed, and no damages were found in the introducer sheath; however, it was returned with blood showing evidence of use.The twist lock was opened.The main coil and the pusher wire were interlocked inside the introducer sheath.The main coil and introducer sheath were inspected, and no anomalies or damages were observed.The pusher wire was found kinked.No more damages were observed.Functional inspection was performed, and the pusher wire and the coil were advanced through the introducer sheath.It was pulled out backwards in order to release the main coil without issues.Microscope inspection of the main coil and the pusher wire revealed that the proximal end has a smooth surface.The interlocking arm was inspected, and no anomalies was noted.Dimensional inspection of the main coil and the pusher wire revealed that the components were within specification.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the coil protruded from the catheter's tip during removal.The non-stenosed target lesion was located in the severely tortuous and non-calcified splenic artery.A 22mm x 60cm interlock coil was selected for use.During the procedure, the coil became stuck in the distal part of the catheter.When the coil was removed from the patient's body, it was noted that the coil protruded from the tip of the microcatheter.Only the coil was removed and the procedure was completed with another of same device.No patient complications were reported.

• 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: 14575444
• Report Number: 2134265-2022-06038
• Device Sequence Number: 6147045
• Product Code: KRD
• UDI-Device Identifier: 08714729845324
• UDI-Public: 08714729845324
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2022

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: 07/27/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0027919147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 07/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER - CARRY LEON LUMEN 0.022 INCH; CATHETER - CARRY LEON LUMEN 0.022 INCH
• Patient Sex: Unknown