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

Model Number 83779

Device Problems Difficult to Remove (1528); Stretched (1601); Failure to Advance (2524)

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

Event Date 09/06/2022

Event Type  malfunction  

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 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
• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15973533
• MDR Text Key: 306713779
• Report Number: 2124215-2022-52149
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729765004
• UDI-Public: 08714729765004
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K132578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2022
• 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
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 52 KG