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	01/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2022.It was reported that the coil could not be advanced into the microcatheter.A 22mm x 60cm interlock was selected for use.During the procedure, it was noted that the coil could not be advanced into the microcatheter.The procedure was completed with another of the same device.There were no patient complications reported and patient was stable.However, device analysis revealed that there was a missing fiber bundles.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The main coil, pusher wire and introducer sheath were returned for this complaint.The main coil and the pusher wire were interlocked within the introducer sheath.The introducer sheath was inspected, and no damages were noted.The twist lock was opened and the pusher wire was found to be kinked.The main coil was also found kinked and stretched.The delivery/pusher wire was advanced through the introducer sheath; however, it was not possible to continue advancing, as the coil was stuck.The introducer sheath was cut, in order to release the main coil.The zap tip was inspected and had a smooth surface.The interlocking arm was inspected, and no anomalies was noticed.The proximal end has a smooth surface.The interlocking arm was inspected, and no anomalies was noticed.The dimensional inspection revealed that the outer diameter (od) at the zap tip and primary coil were found to be within specification.However, the number of fiber bundles were missing, due to the stretched coil condition.

• 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: 13877902
• Report Number: 2134265-2022-02905
• Device Sequence Number: 14582753
• Product Code: KRD
• UDI-Device Identifier: 08714729845324
• UDI-Public: 08714729845324
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2022

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: 05/18/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0027517190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2021
• 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 Age: 70 YR
• Patient Sex: Female
• Patient Weight: 60 KG