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

Catalog Number	LR-EVN-13.0-RL
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	12/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The pma/510(k) # - k141148.Device - the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of investigation.
Event or Problem Description
It was reported that during the course of the lead extraction procedure, a small bleed occurred in a minor branch of the innominate vein.Intervention was required in the form of a chest drain and both leads were extracted successfully.According to the initial reporter, after putting the drain in and continuing with the lead extraction, "patient is fine." the leads had been implanted for over 17 years.No additional patient consequences were reported.
Event or Problem Description
See additional mfr narrative for the investigation of this event.
Additional Manufacturer Narrative
Pma/510(k) # - k141148.Investigation summary: the affected product was not returned for this complaint and therefore a physical investigation could not be performed.The instructions for use was reviewed and listed as a potential adverse event is 'laceration or tearing of vascular structures or the myocardium'.This complaint event is a known failure mode and will be monitored and trended through the complaint handling and post market processes.A device history record review 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 could only be confirmed through customer testimony.

• 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: 7171523
• Report Number: 2522007-2018-00001
• Device Sequence Number: 1043137
• Product Code: DRE
• UDI-Device Identifier: 10827002237473
• UDI-Public: (01)10827002237473(17)200131(10)N143768
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2018

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 Catalogue Number: LR-EVN-13.0-RL
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2017
• Supplement Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 01/08/2018
• Supplement Report FDA Received Date: 08/24/2018
• 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: 73 YR