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

Model Number 83786

Device Problem Difficult to Insert (1316)

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

Event Date 03/20/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device was received for product analysis.The main coil and the delivery wire were returned inside the introducer sheath.The main coil and the delivery wire were not interlocked.The twist lock was opened, and blood was observed inside the introducer sheath.Visual and microscopic inspection revealed that the main coil was detached at the coil arm section, and the coil was bent and stretched at the coil arm section and zap tip section.It was necessary to make cuts in the introducer sheath in order to free the main coil.No more damages were observed.Functional testing could not be performed since the main coil and the delivery wire were not interlocked.The coil dimensions that could be measured were inspected and were within specification.

Event Description

Reportable based on device analysis completed on (b)(6) 2023.It was reported that the coil could not enter the imaging catheter.A 15mmx40cm interlock-35 coil was selected for use in the venous gastric fundus to treat esophagogastric variceal bleeding (egvb).During the transjugular intrahepatic portosystemic shunt (tips) procedure, the imaging catheter had entered the vein with esophagogastric varices (egv), then this coil device was used but could not enter the imaging catheter.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.However, device analysis revealed that the main 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: 17019726
• MDR Text Key: 316145301
• Report Number: 2124215-2023-22040
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729793144
• UDI-Public: 08714729793144
• 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: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• 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: 0030144699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2022
• 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 - RENEGADE
• Patient Age: 66 YR
• Patient Sex: Female