MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK COIL PUSHER-16; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number M0014012160

Device Problems Bent (1059); Fracture (1260); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 09/01/2014

Event Type  malfunction  

Event Description

It was reported that the coil pusher was broken.The patient was being treated for liver cancer and the physician decided to do coil embolization.When the 177cm coil pusher-16 was unpacked, it was found to be "broken/bent" at the distal tip.The procedure was completed with another of the same device.No patient complications were reported and the patient status is good.

Manufacturer Narrative

Patient age at time of event: 18 years or older.(b)(4).Device evaluated by manufacturer: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.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 prior to patient contact.(b)(4).

Event Description

It was previously reported the coil pusher 16 177cm was broken which has been corrected to bent.It was further reported they noticed the bend in the delivery wire prior to insertion of this device into the micro catheter.

• Brand Name: COIL PUSHER-16
• 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: 4130160
• MDR Text Key: 4791325
• Report Number: 2134265-2014-05987
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• PMA/PMN Number: K914786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: M0014012160
• Device Catalogue Number: 401216
• Device Lot Number: 16843024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2014
• 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
• Treatment: MICRO CATHETER: TANGENT SOFT; COIL: 18 TORNADE; GUIDE WIRE: TRANSCEND EX; INTRODUCER SHEATH: 4FR SHEATH