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

Model Number M001361630

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2016

Event Type  malfunction  

Manufacturer Narrative

Age at time of e vent: 18 years and above.(b)(4).Device evaluated by manufacturer: a pusher wire and introducer sheath were returned.The introducer sheath was inspected and no anomaly was noted.The twist lock of the introducer sheath was found closed.The pusher wire was found inside the introducer sheath.The pusher wire was inspected and was found with a slightly amount of blood residues, also was found with the interlocking arm broke and stretched.The interlocking arm of the pusher wire was microscopically inspected and was found broken.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.

Event Description

Reportable based on completed analysis on (b)(6) 2016.It was reported that the coil was missing.A 14mmx20cm interlock¿ was selected to be used and advanced into the patent.During the procedure, under contrast medium inside the patient it was noticed there was no coil.The device was removed from the patient¿s body.The procedure was completed with another of the same device.No patient complications reported and patient¿s status was stable.It was noted "there was no coil when the physician open the package." however, device analysis revealed that the interlocking arm of the pusher wire was broken.

• Brand Name: INTERLOCK¿
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6187013
• MDR Text Key: 62790819
• Report Number: 2134265-2016-11533
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K060078
• 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: 11/29/2016

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 Expiration Date: 09/30/2017
• Device Model Number: M001361630
• Device Catalogue Number: 36-163
• Device Lot Number: 0017402418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2016
• Initial Date FDA Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2014
• 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