MAUDE Adverse Event Report: COOK VANDERGRIFT INC LEAD EXTRACTION EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET; DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHERIZATION

Catalog Number LR-EVN-SH-9.0-RL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Great Vessel Perforation (2152)

Event Date 02/05/2024

Event Type  Injury  

Manufacturer Narrative

The event is currently under investigation.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available or upon completion of investigation.D2b ¿ product code: dre.G5 ¿ pma/510(k): 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.

Event Description

Target site was right atrium and approached from right subclavian vein.When an approach was initiated using lr-evn-sh-9.0-rl for a lead from the right subclavian (not sure if it was an atrial or ventricular lead), the patient's blood pressure dropped prematurely.It was determined that the area around the svc (superior vena cava) had been damaged, and a philips occlusion balloon was delivered through the right inguinal meridian in an attempt to stop the bleeding, but the balloon did not lift and the patient underwent thoracotomy.In the right-sided case, the sheath does not anatomically reach the svc, so it cannot be determined if evn is directly related to the svc injury.The relationship between evn and this event is unknown.Although our sales rep had received a report from the distributor that "open chest" was performed in this case, he did not report it because he was told that "no cook product was used" at that time.However, on 3/22, a clinical engineer from (b)(6) hospital called our sales rep and told him that evn was used, so he reported this time.

• Brand Name: LEAD EXTRACTION EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET
• Type of Device: DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHERIZATION
• Manufacturer (Section D): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer (Section G): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer Contact: timothy vogel ; 1186 montgomery lane; vandergrift, PA 15690 ; 7248458621
• MDR Report Key: 19050860
• MDR Text Key: 339552542
• Report Number: 2522007-2024-00015
• 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: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2024

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-SH-9.0-RL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2024
• 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): Required Intervention
• Patient Sex: Male