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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Rupture (2208); No Code Available (3191)
Date of Event	09/08/2016
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 a (b)(6) male patient underwent a lead extraction from a superior approach, from the subclavian vein down to the right ventricle procedure.During the procedure the physician noticed that the patient's blood pressure was decreasing.After trying to stabilizing the patient without positive results the physician decided to open the chest via a sternotomy to immediately control the ra and the ivc.A small tear was detected at the ivc.However, it was patched.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.
Additional Manufacturer Narrative
(b)(4).K141148.Investigation: a review of complaint history, device history record, documentation, instructions for use (ifu), quality control (qc) and manufacturing instructions (mi) was conducted during the investigation.No device, x-rays, nor images were provided to assist in the investigation.Based on the complaint description there was a rupture of the vena cava inferior during a difficult explantation requiring a sternotomy to be performed.Laceration or tearing of vascular structures is a known adverse event of the device.There is no evidence to indicate that this device was not manufactured to current cvi processes and specifications.There will be no further action taken at this time.
Event or Problem Description
It was reported that a (b)(6) male patient underwent a lead extraction from a superior approach, from the subclavian vein down to the right ventricle procedure.During the procedure the physician noticed that the patient¿s blood pressure was decreasing.After trying to stabilizing the patient without positive results the physician decided to open the chest via a sternotomy to immediately control the ra and the ivc.A small tear was detected at the ivc.However, it was patched.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.

• 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: 6002714
• Report Number: 2522007-2016-00005
• Device Sequence Number: 80297
• Product Code: DRE
• UDI-Device Identifier: 10827002237473
• UDI-Public: (01)10827002237473(17)190430(10)N137167
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2016

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-EVN-13.0-RL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/06/2016
• Supplement Report FDA Received Date: 02/20/2017
• 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: Life Threatening
• Patient Age: 67 YR