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

Model Number	83779
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 02mar2022.It was reported that the coil was unable to advance within the sheath.A 22mmx60cm interlock coil was selected for use on an ovarian vein embolization.During the course of the procedure, the introducer sheath of the device was placed snug to the microcatheter hub (but not too tightly).The introducer sheath was untwisted, and a small amount of advancement of the delivery wire was done before resistance was felt.It was noted that the coil was unable to push any further within introducer sheath and it had not exited introducer sheath.The procedure was completed via alternative method.No patient complications were reported.However, device analysis revealed that there were missing fiber bundles.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.Visual inspection revealed that the main coil and the pusher wire were not interlocked within introducer sheath.Introducer sheath was observed, and no damages were noted.Twist lock was opened.The pusher wire was observed, and it was kinked.The main coil was found kinked and stretched.No more damages were found in the device.Microscopic inspection of main coil and pusher wire revealed that the zap tip has a smooth surface.The interlocking arm was inspected, and no anomalies was noticed.Dimensional inspection of the pusher wire and main coil revealed the components were within specification except the number of fiber bundles, which were below specification.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; 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: 13933267
• Report Number: 2134265-2022-03460
• Device Sequence Number: 3889155
• Product Code: KRD
• UDI-Device Identifier: 08714729845324
• UDI-Public: 08714729845324
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 03/28/2022

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: 07/19/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0027870845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2021
• 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