MAUDE Adverse Event Report: COOK VASCULAR INC LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET; DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	N/A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Hemostasis (1895); Low Blood Pressure/ Hypotension (1914); Laceration(s) (1946)
Date of Event	07/06/2017
Type of Reportable Event	Serious Injury
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 an intracardiac defibrillator extraction for infection on a patient.The physician used lead extraction evolution rl controlled-rotation dilator sheath set during the procedure.Soon after the blood pressure dropped, the physician found a tear in superior vena cava innominate vein.The physician placed a balloon from a different manufacturer to control bleeding and a surgeon was called in.The surgeon performed an open chest surgical repair.After the chest was opened, an aortic tear was noted.The tear was due to the excessive manipulation needed as the patient had severe scarred anatomy.The patient was in stable condition post-surgery.No unintended sections of the device remain inside the patient¿s body.Additional information is requested from the customer.
Additional Manufacturer Narrative
(b)(4).Pma/510(k)# k141148.Investigation summary: the affected product was not returned for physical examination and no photographs were provided.The complaint could only be confirmed through customer testimony.A quality engineering risk assessment (qera) was completed which reveal vascular tear is a known failure mode.The instructions for use were reviewed and listed as a potential adverse event is 'laceration or tearing of vascular structures or the myocardium'.A review of device history record for this lot number was performed including the manufacturing and quality control records.All steps were documented per procedure by trained personnel and there were no signs to indicate that a nonconforming device was released to the field.This complaint will be logged and tracked in the complain handling process.The device was not returned, and therefore a determination if the device was defective is inconclusive.

• Brand Name: LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
• Common Device Name: DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 6753832
• Report Number: 2522007-2017-00027
• Device Sequence Number: 139012
• Product Code: DRE
• UDI-Device Identifier: 10827002237473
• UDI-Public: (01)10827002237473(17)200131(10)N143995
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2018

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-EVN-13.0-RL
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/06/2017
• Supplement Date Received by Manufacturer: 07/06/2017
• Initial Report FDA Received Date: 07/31/2017
• Supplement Report FDA Received Date: 04/06/2018
• 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: 35 YR