MAUDE Adverse Event Report: COOK VASCULAR INC LEAD EXTRACTION STEADYSHEATH¿ EVOLUTION® TISSUE STABILIZATION SHEATH; DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	G25084
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	12/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is associated with manufacturer report # 2522007-2018-00001.(b)(4).The 510(k) # - k142301.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 h10 for investigation of this event.
Additional Manufacturer Narrative
Product code dre.510(k)# k142301.Device code desc changed to adverse event without identified device or use problem (2993).Ec method code changed to device not returned (4114).Ec results code desc changed to no findings available (3221).Ec conclusions code desc 1 changed to known inherent risk of device (22).Summary of investigation: the lr-tss-13.0 device was not returned for this complaint investigation, therefore no physical investigation by the quality engineering and engineering departments was performed.No photo's or x-rays were provided.The device was not returned, therefore a determination if the device was defective is inconclusive.The ifu was reviewed, and listed in the ifu 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 via the complaint handling and post market processes at cvi.A risk assessment was conducted and it was determined that no further risk reduction is necessary.A device history record review for this lot number-n141080 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 report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: LEAD EXTRACTION STEADYSHEATH¿ EVOLUTION® TISSUE STABILIZATION SHEATH
• Common Device Name: DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 7178237
• Report Number: 2522007-2018-00002
• Device Sequence Number: 1158164
• Product Code: DRE
• UDI-Device Identifier: 00827002250840
• UDI-Public: (01)00827002250840(17)190930(10)N141080
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2019

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 Expiration Date: 09/30/2019
• Device Model Number: G25084
• Device Catalogue Number: LR-TSS-13.0
• Device Lot Number: N141080
• 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: 01/10/2018
• Supplement Report FDA Received Date: 01/08/2019
• 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