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	Device Slipped (1584)
Health Effect - Clinical Codes	Unspecified Infection (1930); Atrial Perforation (2511)
Date of Event	11/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that during a lead extraction procedure, a liberator and one tie was used.While using traction to extract the lead, the liberator and one tie slipped and pulled away from the lead tip.The physician then attached suture ties to the lead to try and make it more secure, then as more traction was used, the lead snapped and the locking stylet and partial lead came out.The patient suffered a right atrial perforation.The physician performed a sub xiphoid window and repaired the perforation.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Correction of contact information.Investigation - evaluation.A review of device history record, documentation, quality control, manufacturing instructions, and complaint history was conducted during the investigation.The product will not be returned for the investigation.If the device becomes available complaint will be reopened and investigation will be performed at that time.Review of production and quality documentation did not observe any specific issues with current controls that may have contributed to this incident.Review of device history record did not observe any non-conformances that may have contributed to this incident.Based on the provided information a definitive root cause cannot be established or reported at this time.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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: 6169383
• Report Number: 2522007-2016-00016
• Device Sequence Number: 16322929
• Product Code: DQX
• UDI-Device Identifier: 00827002265509
• UDI-Public: (01)00827002265509(17)190930(10)N141202
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2017

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
• Initial Date Received by Manufacturer: 11/20/2016
• Supplement Date Received by Manufacturer: 06/02/2017
• Initial Report FDA Received Date: 12/13/2016
• Supplement Report FDA Received Date: 09/05/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR