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

Model Number 83786

Device Problem Premature Activation (1484)

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

Event Date 03/31/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The main coil return inside a non-boston scientific catheter, a torque device also returns.The main coil was observed bent, detached and stretched at the coil arm section.No more damages were observed.Microscope inspection revealed that under the microscope it was observed that the main coil was observed bent, detached and stretched at the coil arm section.Functional inspection.The functional test could not be performed due only the main coil returned.Dimensional inspection revealed that the overall dimension of the zap tip, primary coil and the coil arm of the main coil were within the specification.

Event Description

Reportable based on device investigations completed on (b)(6) 2023.It was reported that premature deployment occurred.The target lesion was located in the varicose veins of the fundus of the stomach with severe tortuosity.A 6mm x 20cm interlock.035 was selected for use.During the procedure, it was noted that the interlocking arm of the coil detached/unlocked from the interlocking arm of the pusher wire.The coil and the catheter were removed directly as a whole and the procedure was completed with another of the same device.There were no complications and the patient is stable.However, device analysis revealed that the coil was detached at the coil arm section.

• 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: 17107066
• MDR Text Key: 316996130
• Report Number: 2124215-2023-25262
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729793021
• UDI-Public: 08714729793021
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• 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: 0030074228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2022
• 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
• Treatment: MICROCATHETER-CORDIS 5F 0.038 INCH BORE
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 63 KG