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

Model Number	83779
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device eval by manufacturer: the main coil, the pusher wire, and the introducer sheath were returned.Visual and microscopic inspection revealed the interlocking arm and the main coil were not interlocked.The twist lock was opened.Blood was noticed inside the introducer sheath.The pusher wire was detached/separated at the mid solder joint section.The coil wire of the pusher wire was stretched, and the interlocking arm was bent.The introducer sheath was cut during analysis to release the main coil.The functional inspection could not be performed due to the pusher wire being detached.Dimensional inspection revealed that the pusher wire and main coil were within specification.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 15nov2022.It was reported that the coil was unable to advance in the introducer sheath and was stretched.The target lesion was located in the gastric venous.A 6mm x 20cm interlock was selected for use.During the procedure, it was noted that the coil was unable to advance in the introducer sheath and it was stretched.The entire catheter was removed and the procedure was completed with another of the same device.No complications were reported and patient was stable post procedure.However, device analysis revealed that the pusher wire was detached/separated at mid solder joint section.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15973533
• Report Number: 2124215-2022-52149
• Device Sequence Number: 20359192
• Product Code: KRD
• UDI-Device Identifier: 08714729765004
• UDI-Public: 08714729765004
• 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): 12/13/2022

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: 12/06/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0028636899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2022
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 52 KG