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

Model Number M001361740

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that the tip of the coil was broken.A 2/3mm x 2.3cm vortx diamond interlock¿ coil was selected for an embolization procedure.During preparation, the physician noted that the tip of the coil came off and had become disconnected.The physician returned everything they had on the table and the procedure was completed with a different device.No patient complications were reported as the device did not enter the patient's body.

Manufacturer Narrative

(b)(4).Device evaluated by mfr.: a dispenser hoop, introducer sheath and pusher wire were returned.During visual inspection, the ss coil region of the pusher wire was noted to be protruding from the introducer sheath.The pusher wire was kinked distally.No damage was observed to the introducer sheath.No coil was returned.A further microscopic inspection noted the interlocking arm of the pusher wire to have no damage.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 considered handling damage as the event occurred without direct patient contact.(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: 4483444
• MDR Text Key: 16304286
• Report Number: 2134265-2015-00730
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060078
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• 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: M001361740
• Device Catalogue Number: 36-174
• Device Lot Number: 17380269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2014
• 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