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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)
Date of Event	08/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G5 ¿ pma/510(k): k141148.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.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 or Problem Description
Attempted to detach the adhesion of the atrial lead with evnsh9, the blood pressure dropped to about 20 when the tip of the inner sheath was about to enter the subclavian vein and has not risen since.Probably pericardial drainage and possibly open thoracotomy.On 23 august 2023 additional information was obtained: target site was right atrium and access site was left subclavian vein.On 23 august 2023 additional information was provided by the physician: the cause of cardiac tamponade that occurred during lead removal using cook products(evn and ofa) was that the lead tip, which was tined to the inner wall of the atrium, rupture the atrium.The reason why the lead tip ruptured the atrium was the structure of the lead structure (tined tip (passive fixation) , not those cook products.The rupture area was immediately opened and sutured surgically.
Additional Manufacturer Narrative
G5 ¿ pma/510(k): k141148.The device was not returned for the complaint, therefore a physical investigation could not be performed and the customer's complaint could not be confirmed, other than by the customer's testimony.The complaint/event that was entered and reported within trackwise: "pericardial tamponade." the device history record (dhr) was reviewed, including manufacturing and quality control records and there are no signs to indicate that the device was not manufactured to current specifications.This complaint mode will be tracked, trended and monitored in cvi complaint handling and post market surveillance procedures.A risk assessment will be performed within the complaint summary tab of trackwise.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 or Problem Description
Attempted to detach the adhesion of the atrial lead with evnsh9, the blood pressure dropped to about 20 when the tip of the inner sheath was about to enter the subclavian vein and has not risen since.Probably pericardial drainage and possibly open thoracotomy.On 23 august 2023 additional information was obtained: target site was right atrium and access site was left subclavian vein.On 23 august 2023 additional information was provided by the physician: the cause of cardiac tamponade that occurred during lead removal using cook products (evn and ofa) was that the lead tip, which was tined to the inner wall of the atrium, rupture the atrium.The reason why the lead tip ruptured the atrium was the structure of the lead structure (tined tip (passive fixation) , not those cook products.The rupture area was immediately opened and sutured surgically.

• Brand Name: LEAD EXTRACTION EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET
• Common Device Name: 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: 17622794
• Report Number: 2522007-2023-00015
• Device Sequence Number: 20658442
• Product Code: DRE
• UDI-Device Identifier: 00827002237483
• UDI-Public: (01)00827002237483(17)260331(10)N195228
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Catalogue Number: LR-EVN-SH-9.0-RL
• Device Lot Number: N195228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LR-OFA01; LR-OFA01; LR-OTE-N; LR-OTE-N
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male