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

Catalog Number LR-EVN-13.0-RL

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

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 04/01/2024

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicated the information is unknown, unchanged, or unavailable.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

As initially reported to customer relations: a 72-year-old male patient underwent a lead extraction with superior approach instruments procedure in which the lead extraction evolution rl controlled-rotation dilator sheath sets, g23746 and g23747, were used.3x locking stylets, 4x one-ties, 1x bulldog were used.The 11fr shortie with steady sheath and 11fr evolution with steady sheath were used to extract the ra lead, then 13fr evolution with steady sheath were advanced part way onto the rv lead.The physician noticed blood pressure dropping and proceeded with sternotomy.After patient was stable, the 13fr evolution and steady sheath were used to extract the rv lead, and 11fr evolution with steady sheath were used to extract the lv lead.

• Brand Name: LEAD EXTRACTION EVOLUTION 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: 19044440
• MDR Text Key: 339434607
• Report Number: 2522007-2024-00016
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LR-EVN-13.0-RL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Treatment: G23746/LR-EVN-11.0-RL; G26550/LR-OFA01; G31929/LR-OTE-N; G46542/LR-LED01
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Male