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

Model Number	83779
Medical Device Problem Codes	Separation Failure (2547); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by manufacturer: the device was returned for analysis.Visual inspection revealed that the pusher wire and introducer sheath were returned for this complaint.The twist lock of the introducer sheath had been opened.The introducer sheath was inspected, and no anomalies were noted.The pusher wire was inspected and was found kinked.Microscopic inspection of the pusher wire revealed that the proximal end has a smooth surface.The interlocking arm was inspected, and it was detached (part was not returned.Dimensional inspection of the pusher wire revealed that the outer diameter (od) of the mid solder joint, distal tfe and proximal tfe are within the specification.However, the od of the distal solder joint could not be performed.
Event or Problem Description
Reportable based on device analysis completed on 20apr2021.It was reported that the coil could not be deployed.A 3mmx6cm interlock was selected for use.During procedure, multiple coils were used however this device could not be deployed all the time.Subsequently, the deploy clasp was partially fixed and could not be deployed when withdrawn from the patient's body.The procedure was completed with another of the same device.There were no complications reported and the patient is stable.However, device analysis revealed a detached interlocking arm and not returned.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11809936
• Report Number: 2134265-2021-06044
• Device Sequence Number: 3436592
• Product Code: KRD
• UDI-Device Identifier: 08714729764939
• UDI-Public: 08714729764939
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/11/2021

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: 08/16/2023
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0026021605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1