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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).K142301.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 intended pacemaker lead extraction procedure to remove and replace a previously damaged implantable cardioverter defibrillator (icd) lead made by another manufacturer.The physician used a lead extraction steadysheath® evolution® tissue stabilization sheath during this procedure.Due to heavily calcified scar tissue, the icd lead broke.During the icd lead removal, the metal tip of the lead extraction steadysheath® evolution® tissue stabilization sheath broke off in the patient¿s clavicle.A new introducer was required to gain access to the patient's vascular system.It was further reported that the physician was unable to retrieve the broken piece of the metal tip; therefore it was left inside the patient¿s body.An additional procedure will be necessary to remove the tip from the patient.Additional information was requested regarding this event.No additional information has been provided at this time.
Additional Manufacturer Narrative
G5-510(k) # k142301.Investigation summary: the complaint device was returned for a physical examination.X-rays and photographs were provided and reviewed.A visual inspection confirmed the sheath tip had disconnected.The sheath had uneven surfaces (bends) on the inner and outer diameters.The wall appears to have been breached by the evolution turning action being engaged while inside the sheath, at one of the curves or turns of the sheath causing the sheath wall to peel away, and the tip then pulling off.The section that peeled away was not returned for investigation.The device history record was reviewed for this lot and there were no signs that the steady sheath was manufactured outside of specification and that nonconforming product was released to the field.

• 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: 6633480
• Report Number: 2522007-2017-00023
• Device Sequence Number: 11586
• Product Code: DRE
• UDI-Device Identifier: 00827002250840
• UDI-Public: (01)00827002250840(17)191031(10)N141635
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2018

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 Expiration Date: 10/31/2019
• Device Model Number: N/A
• Device Catalogue Number: LR-TSS-13.0
• Device Lot Number: N141635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Initial Date Received by Manufacturer: 05/19/2017
• Supplement Date Received by Manufacturer: 05/19/2017
• Initial Report FDA Received Date: 06/12/2017
• Supplement Report FDA Received Date: 11/27/2018
• 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: Other; Required Intervention
• Patient Age: 58 YR