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 Codes	Device Operates Differently Than Expected (2913); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Death (1802)
Date of Event	03/21/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
It was reported that the physician was performing a lead removal procedure to extract a non-functional implantable cardioverter defibrillator (icd) lead which was implanted from right side.The blood pressure was 210/100mmhg at the beginning of the procedure.The lead was prepped using a lead extraction liberator beacon tip locking stylet.The physician began the extraction using a laser sheath from a different manufacturer.The use of the laser sheath was stopped when it could not make any further progress at the innominate vein / superior vena cava junction.The physician pulled the lead and the blood pressure dropped to 50mmhg.The physician applied chest compressions and administrated adrenaline.An effusion was noted and the lead was extracted manually by simple traction.Percutaneous cardiopulmonary support (pcps) was applied.The physician immediately performed a pericardial drainage.Blood pressure was restored to 80mmhg.The physician noted the effusion again and the blood pressure dropped again.The patient was transferred to the operating room and a sternotomy was performed.A tear of about 7cm was confirmed at the right atrium wall.The tear was repaired under open chest surgery.Defibrillation was applied repeatedly but the patient could not survive the procedure.No further information is available at the moment.
Additional Manufacturer Narrative
(b)(4).Added investigation summary.Investigation summary: the affected product was not returned for a physical examination.No photos or x-rays were provided.The device history record was reviewed as well as manufacturing and quality control records and processes.There is no evidence to indicate that this device was not manufactured to current processes and specifications, or that it was released to the field nonconforming.This complaint will be logged and tracked in the complaint handling process.No conclusion could be dawn since a physical examination was not performed.

• 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: 6541747
• Report Number: 2522007-2017-00016
• Device Sequence Number: 1134432
• Product Code: DQX
• UDI-Device Identifier: 00827002265509
• UDI-Public: (01)00827002265509(17)190531(10)N137779
• Combination Product (Y/N): N
• PMA/510(K) Number: K970690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2018

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: 04/03/2017
• Supplement Date Received by Manufacturer: 04/03/2017
• Initial Report FDA Received Date: 05/03/2017
• Supplement Report FDA Received Date: 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LASER SHEATH (14F SLSII) (SPECTRANETICS)
• Outcome Attributed to Adverse Event: Death