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

Model Number M001361960

Device Problems Device Damaged Prior to Use (2284); Malposition of Device (2616)

Patient Problem No Patient Involvement (2645)

Event Date 02/23/2015

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 15apr2015.It was reported that the coil was out of the introducer.A 22mm x 60cm interlock¿ was selected for use.During preparation, when the coil was pulled out from the protective hoop, it was noted that the coil and pusher wire had been completely pulled out from the introducer.The device was not used and the procedure was completed with another of the same device.There were no patient complications reported and the patient's condition was stable.However, device analysis revealed that the interlocking arm of the pusherwire had broken off.

Manufacturer Narrative

(b)(4).An introducer sheath, pusher wire and coil were returned for analysis.A visual inspection was performed and the coil and pusher wire were not interlocked.The pusher wire was noted to be kinked and stretched.The interlocking arm of the pusher wire had broken off and was not returned.The coil was returned within the introducer sheath.A microscopic inspection was performed and the interlocking arm of the pusher wire was broken off.The interlocking arm of the coil was inspected and no damage noted.The coil zap tip was inspected and no damage noted.The dimensions that could be measured were found to be in specification.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4765229
• MDR Text Key: 5779007
• Report Number: 2134265-2015-02819
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K060078
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2015
• 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: M001361960
• Device Catalogue Number: 36-196
• Device Lot Number: 0017368432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2014
• 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