MAUDE Adverse Event Report: COOK VASCULAR INC LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET; DQX WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Investigation: a review of complaint history, device history record, quality control (qc) and a visual inspection was conducted during the investigation.The portion of the device proximal to the fracture was returned, along with the handle.The outer shaft of the device and distal portion of the inner wire were not returned, nor were photographs provided.Visual inspection confirmed the device fractured approximately ~8.5 cm from the solder joint.The site of the fracture was observed under magnification, and no signs of chemical attack or brittleness were observed.It appears the fracture was ductile in nature.No nonconformities were observed in the solder joint, and no signs of tool use, kinks, or pressure points were observed on the device.No other nonconformities were observed on the device.Manufacturing records for this device were reviewed and there are no signs that nonconforming product was released.No other complaints have been filed for this device lot.Qc records for the inner wire of the device were reviewed and found to meet cvi acceptance criteria.The complaint was confirmed through visual observation of the device.Because no signs of nonconformity or misuse were found, it appears this device sustained excessive force in a longitudinal direction.It does not appear the device was misused or that tools were used to generate additional force on the device.The appropriate internal personnel have been notified.We will continue to monitor for similar complaints.
Event or Problem Description
Midway into the case the lead extraction liberator beacon tip locking stylet broke about 5cm distal to the weld where it attaches to the braided handle.There was enough of the liberator remaining outside of the proximal to where the surgeon, using hemostats, could grab and successfully remove the lead.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 5444340
• Report Number: 1820334-2016-00079
• Device Sequence Number: 16243817
• Product Code: DXQ
• UDI-Device Identifier: 00827002265509
• UDI-Public: (01)00827002265509(17)181031(10)N132763
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K970690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: LR-OFA01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/01/2016
• Device Age: 3 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2016
• Initial Report FDA Received Date: 02/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention