MAUDE Adverse Event Report: COOK VASCULAR 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 Problem Tricuspid Regurgitation (2112)

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Date of event: unknown; product code: dre.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: "new tool to overcome lead fibrous binding sites: a word of caution." device used to remove 2 rv leads implanted.Both leads were successfully removed but a massive tricuspid regurgitation was diagnosed by transthoracic echocardiography.It was successfully repaired and patient was discharged several days after surgery.

Manufacturer Narrative

Pma/510(k)# k142301.Investigation summary: the complaint device was not returned for a physical investigation.A determination if the device was defective is inconclusive.The instructions for use was reviewed and listed as possible potential adverse events are: 'laceration or tearing of vascular structures or the myocardium/cardiac tamponade'.This complaint event is a known failure mode and will be monitored per the complaint handling and post market processes.The lot number is unknown and therefore the device history record review was not performed.

• Brand Name: LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
• Type of Device: VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 7969212
• MDR Text Key: 123834142
• Report Number: 2522007-2018-00026
• 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: 11/26/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: LR-EVN-11.0
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2018
• Initial Date FDA Received: 10/16/2018
• Supplement Dates Manufacturer Received: 09/21/2018
• Supplement Dates FDA Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR