MAUDE Adverse Event Report: COOK VASCULAR INC LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

Model Number N/A

Device Problems Membrane tear(s) (1391); Appropriate Term/Code Not Available (3191)

Patient Problems Death (1802); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure, additional (2564)

Event Date 05/29/2015

Event Type  Death  

Event Description

The (b)(6) female patient with pre-existing condition of pacemaker lead malfunction was having an ivc (inferior vena cava) procedure.There was a tear during extraction of the lead; which had been implanted (b)(6) 2006.The physician stated he was not even in the ivc.New information received on (b)(6)2015: removal of the lead resulted in an ivc tear.The 11 fr lead extractor rl did not make contact with the ivc.The chest was opened to locate the bleed in the ivc.The patient expired.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Manufacturer Narrative

Common name: dre dilator, vessel for percutaneous catherization (b)(4).Event evaluation: a review of complaint history was conducted during the investigation.This device will not be returned for evaluation.No photos were provided, and the device's lot number was not provided.Therefore, a full investigation cannot be performed.Comments within the complaint indicate that a tear in the inferior vena cava was found following removal of a lead, and that the device(s) used did not make contact with the ivc.There is no evidence to suggest the device malfunctioned or was nonconforming.There is no evidence to suggest the product was not manufactured to specification.

Event Description

The (b)(6) female patient with pre-existing condition of pacemaker lead malfunction was having an ivc (inferior vana cava) procedure, there was a tear during extraction of the lead; which had been implanted (b)(6) 2006.The physician stated he was not even in the ivc.New information received on 02june2015: removal of the lead resulted in an ivc tear.The 11 fr lead extractor rl did not make contact with the ivc.The chest was opened to locate the bleed in the ivc.The patient expired.

• Brand Name: LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 4871955
• MDR Text Key: 18093637
• Report Number: 1820334-2015-00376
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: LR-EVN-11.0-RL
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/29/2015
• Device Age: NA
• Event Location: Hospital
• Date Manufacturer Received: 06/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 66 YR