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

Model Number 83787

Device Problems Premature Activation (1484); Physical Resistance/Sticking (4012)

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

Event Date 08/13/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Visual inspection performed showed a main coil, introducer sheath and delivery wire were returned for this complaint.The coil and delivery wire were not interlocked within introducer sheath.All parts returned separated.Coil was noted severely kinked and stretched.The delivery wire was inspected, and no damages were found.The introducer sheath was inspected, and no damages were found.No more damages were found.Microscopic inspection on delivery wire revealed that the proximal end has a smooth surface.The interlocking arm was inspected, and no damages were noticed.Microscopic inspection on main coil revealed that the zap tip has a smooth surface.The interlocking arm was inspected, and no damages were noticed.Dimensional inspection on delivery wire revealed that the weld od (max) outer diameter, wire arm od, wire zap tip (max) were within specification.Dimensional inspection on main coil revealed that the number of distal fiber bundles, zap tip od and primary coil od were within specification.However, a number of proximal fiber bundles were missing.

Event Description

Reportable based on device analysis completed on 28sep2021.It was reported that the device could not be delivered and prematurely deployed.The target lesion was located in the internal iliac artery.A 10mm x 40cm interlock -35 coil was selected for use.During the procedure, the coil could not be delivered.However, when the device was about to be withdrawn from the patient's body, it was released spontaneously in the protective sheath.The device was simply pulled out from the patient's body.The procedure was completed with another of same device.No patient complications were reported and the patient was stable post procedure.However, device analysis revealed that the fiber bundles were incomplete and device was separated.

• Brand Name: INTERLOCK-35
• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12661007
• MDR Text Key: 277369506
• Report Number: 2134265-2021-12455
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729795513
• UDI-Public: 08714729795513
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2024
• Device Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0027092103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2021
• 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 Age: 74 YR