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

Model Number 83777

Device Problems Premature Activation (1484); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: used (b)(6) 2021 as the event date was not reported.

Event Description

It was reported that the coil needed to be snared to remove.A 2/3mmx2.3cm interlock was selected for use.The target lesion was located in a moderately tortuous vessel.During the procedure, the coil was fed into the microcatheter.The physician was not happy with the catheter position, so the coil was pulled out without detaching.The guidewire was placed into the catheter to reposition, but the coil was unexpectedly in microcatheter and was then deployed in suboptimal position.The coil needed to be snared to remove.The procedure was completed with another of the same device.No further patient complications were reported.

• 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 CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11770023
• MDR Text Key: 248815150
• Report Number: 2134265-2021-04933
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729765080
• UDI-Public: 08714729765080
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K132578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2023
• Device Model Number: 83777
• Device Catalogue Number: 83777
• Device Lot Number: 0025680268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2020
• 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
• Treatment: MICROCATHETER - COOK
• Patient Outcome(s): Required Intervention