MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number 83786

Device Problem Failure to Advance (2524)

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

Event Date 05/05/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The main coil and the pusher wire was returned inside the introducer sheath, a torque device also returns.The main coil was observed kinked at the coil arm section and it can observe that the zap tip was detached.The test could not be performed since the pusher wire and the main coil are not interlocking.The dimensional inspection revealed that the outer diameter (od) at the coil arm and primary coil were found to be within specification.

Event Description

Reportable based on device analysis completed on 07jun2023.It was reported that difficulty advancing occurred.A patient who had pelvic siltation underwent embolization of ovarian vein and internal iliac vein.A 8mm x 40cm interlock-35 was selected for use.During the procedure, the last coil was placed at the opening of the ovarian vein, at the time it entered the 5f angiographic catheter and was deployed, it was found that the catheter was not at the correct position and was withdrawn from the patient.After being flushed with heparin saline, it was deployed again.However, the coil could not be advanced inside the tail end of the catheter, but it could be withdrawn.The procedure was completed with another interlock-35.There were no complications reported and the patient was stable post procedure.However, device analysis revealed that the zap tip was detached.

• Brand Name: INTERLOCK-35
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17246074
• MDR Text Key: 318292423
• Report Number: 2124215-2023-29200
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729793014
• UDI-Public: 08714729793014
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K133208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/03/2023

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
• Device Operator: Health Professional
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0029517744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2023
• Initial Date FDA Received: 07/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2022
• 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: 45 YR
• Patient Sex: Female
• Patient Weight: 45 KG