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 Code Available (3191)
Date of Event	01/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
During an electrode pulling technique (heart) procedure on the (b)(6) male patient, the surgeon extracted the electrode and found the locking stylet was detached.The procedure was successfully completed with other equipment.The locking stylet has been removed from the patients body.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation/evaluation although it was advised product would be returned, as of 03 march 2016, no product was returned for evaluation.However, during the course of investigation, a review of the complaint history and device history record was conducted.A review of manufacturing records for the device were reviewed, and no signs of nonconformity were found.A review of quality control records were reviewed, and all components tested met acceptance criteria.As the device was not returned, a full investigation could not be performed.There is no indication that the fracture was caused by nonconforming material, misuse of the device, or an undetected quality issue.Without more information about the device's use or the device itself, the root cause of this complaint cannot be determined.We will continue to monitor this device.
Event or Problem Description
During an electrode pulling technique (heart) procedure on the (b)(6) male patient, the surgeon extracted the electrode and found the locking stylet was detached.The procedure was successfully completed with other equipment.The locking stylet has been removed from the patients body.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not require any additional procedures nor 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: 5444151
• Report Number: 1820334-2016-00090
• Device Sequence Number: 13514527
• Product Code: DXQ
• UDI-Device Identifier: 00827002265509
• UDI-Public: (01)00827002265509(17)180731(10)N130386
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K970690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2016

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?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/28/2016
• Device Age: 5 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2016
• Supplement Report FDA Received Date: 03/03/2016
• 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
• Patient Age: 60 YR
• Patient Weight: 60