MAUDE Adverse Event Report: COOK VANDERGRIFT INC LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET; VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION

Catalog Number LR-EVN-11.0

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Embolus (1830); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Product code: dre.Pma/510(k)#: 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 Description

Per journal article: 'central venous catheter fracture during pacemaker lead extraction', "in this case report, we present an unusual and potentially life-threatening complication of lead extraction, in which a cvc coursing ipsilaterally to the pacemaker leads was fractured during the use of mechanical sheaths.The catheter embolized distally into the right atrium.The polyurethane catheter was likely damaged intraoperatively directly by the use of the laser and evolution mechanical extraction sheaths.To our knowledge, such a complication has not been reported previously in the scientific literature.".

Event Description

No additional patient or event information has been received since the initial report was filed.

Manufacturer Narrative

Section d 2b-product code: dre.Section g 5-pma/510(k)#: k142301.Investigation summary: no lr-evn device was returned to cvi.This complaint was issued due to a literature review, from the libin cardiovascular institute of alberta, university of calgary, calgary alberta canada.The device was not returned to cvi therefore a physical investigation of the device was not performed.The quality engineering department reviewed the provided article.A manufacturing failure/defect of the device could not be confirmed with the information provided.Adverse physiological response is a known failure modes of this device.Laceration or tearing of vascular structures or the myocardium is also listed as a potential adverse event in the instructions for use.This complaint will be monitored and trended through the cvi complaint handling and the post market surveillance processes.A risk assessment will be performed via a qera and documented in the complaint summary tab of trackwise.The dhr could not be reviewed as the lot number was unknown/not provided.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 a death or serious injury if a malfunction occurred.

• Brand Name: LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
• Type of Device: VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 7991007
• MDR Text Key: 124565497
• Report Number: 2522007-2018-00022
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 10/22/2018,02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LR-EVN-11.0
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Report Sent to FDA: 10/22/2018
• Date Manufacturer Received: 09/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6F GOOSENECK-TYPE SNARE; 6F GOOSENECK-TYPE SNARE; 6F GOOSENECK-TYPE SNARE
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR