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

Model Number 83779

Device Problems Entrapment of Device (1212); Fracture (1260); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual and functional inspection revealed that a pusher wire, coil and introducer sheath were returned for this complaint.The coil and pusher wire arms were not interlocked within introducer sheath.The twist lock of the introducer sheath had been opened.The pusher wire was returned kinked.The coil was returned stretched and kinked near the interlocking arm.No more damages were found in the device.The coil was stuck and exit from the introducer sheath with some resistance.A microscopic and dimensional inspection of the main coil and pusher wire revealed that the proximal end of the pusher wire has a smooth surface.The interlocking arm was inspected and no anomalies were noted.However, the zap tip of the main coil has a smooth surface.The coil was returned stretched near the interlocking arm and zap tip.The interlocking arm was inspected and no anomalies were noted.The distal solder joint outer diameter (o.D), mid solder joint o.D, distal tfe o.D and the proximal tfe o.D of the pusher wire were within its specification.However, the zap tip od (max), primary coil od of the main coil were within its specification aside from the missing number of fiber bundles.

Event Description

Reportable based on device analysis completed on 19feb2020.It was reported that the coil was stuck, could not be deployed and stretched upon removal.The target lesion was located in the gastroesophageal vein.A 8mm x 20cm interlock coil was selected for use in gastroesophageal varicose vein embolization.During procedure, it was noted that the coil was stuck and could not deployed.The physician performed it several times, however the coil could not be pushed through.The coil was removed and found out that the it was stretched.However, it was further reported that continuous flushing was performed before introduction of the coil using hand injection.The procedure was completed with another of the same device.No patient complications were reported and patient status was stable.However, device analysis revealed missing fiber bundles.

• Brand Name: INTERLOCK
• 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; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9752306
• MDR Text Key: 181179071
• Report Number: 2134265-2020-02048
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729765011
• UDI-Public: 08714729765011
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K132578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2022
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0023950047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2019
• 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: 56 YR
• Patient Weight: 51