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

Model Number 83786

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

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

Event Date 06/25/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 12sep2023.It was reported that the interlocking arm was stuck on the catheter and the coil had been stretched.The target lesion was in the internal iliac artery.A 2d 10mm x 40cm interlock.035 was selected for use.During the embolization of internal iliac artery, due to the adjustment of shape and position, the device was re-deployed after withdrawal.However, the interlocking arm was stuck in the middle of the catheter, which could neither go forward nor backward.The device was pulled out and it was found that the coil had been stretched.The procedure was completed with another of the same device.No complications reported and the patient is stable.However, device investigations revealed that the main coil was detached at the coil arm section.

Manufacturer Narrative

E1.Initial reporter city- (b)(6).Device evaluated by mfr: the device was returned for evaluation.Only the main coil returned for the analysis.Additionally, it was observed the main coil was stretched, detached and bent at the coil arm section.No more damages can be observed on the device.Microscope inspection revealed that under the microscope it was observed that the main coil was stretched, detached and bent at the coil arm section.The functional test could not be performed due only the main coil returned for the analysis.Dimensional inspection revealed that the outer diameter of diameter of the zap tip and the primary coil of the main coil were within the specification.

• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17889867
• MDR Text Key: 326051271
• Report Number: 2124215-2023-50519
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729793168
• UDI-Public: 08714729793168
• 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: 10/06/2023

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: 0030516812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2022
• 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: DELIVERY CATHETER- VER CATHETER OF CORDIS
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 65 KG