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

Model Number 83779

Device Problem Difficult to Insert (1316)

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

Event Date 10/26/2022

Event Type  Injury  

Event Description

It was reported that insertion difficulties occurred.The 50% stenosed target lesion was located in the mildly tortuous and mildly calcified internal illiac artery.A 14mm x 30cm interlock 2d coil was selected for use.During the procedure, the coil was difficult to insert.The device was removed by snaring from the patient's body and the procedure was completed with a different device.No 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15835278
• MDR Text Key: 304028797
• Report Number: 2124215-2022-46659
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729765073
• UDI-Public: 08714729765073
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0027058801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• 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 Outcome(s): Required Intervention