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

Model Number 83779

Device Problems Difficult to Insert (1316); Physical Resistance/Sticking (4012)

Patient Problem No Patient Involvement (2645)

Event Date 01/10/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.A pusher wire, main coil and introducer sheath were returned for this complaint.The coil and pusher wire arms were not interlocked within introducer sheath.The twist lock of the introducer sheath had been opened.The pusher wire was inspected and no anomalies were noted.The mail coil was returned stretched and kinked.No more damages were found in the returned device.The coil was stuck and exit from the introducer sheath with some resistance.The proximal end has a smooth surface.The interlocking arm was inspected and no anomalies were noted.The zap tip has a smooth surface.The interlocking arm was inspected and no anomalies were noted.Dimensional inspection of the pusher wire and main coil revealed the components were within specification except the number of fiber bundles, which failed to meet specification.

Event Description

Reportable based on device analysis completed on 28feb2020.It was reported that the pusher wire would not advance into the microcatheter.A 6mm x 20cm interlock coil was selected for use.At the course of the procedure, when the physician placed the coil inside a microcatheter, it was noted that the coil would not advance since the pusher wire would not advance into the microcatheter.The coil did not go inside the patient's body.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed that there were missing fiber bundles.

• Brand Name: INTERLOCK
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9825208
• MDR Text Key: 183255549
• Report Number: 2134265-2020-03122
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729765004
• UDI-Public: 08714729765004
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2022
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0024229927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1