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

Model Number	G23746
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Great Vessel Perforation (2152)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
After the procedure, the patient had to undergo surgery because of a blood hemorrhage.After the surgery the user said that the blood could have come from the vena and could have been caused by our product.Once extracted atrial pacemaker without any problem during fibrolisis with evolution 11.0 long shaft, it occurred hemorrhage (pericardial tamponade).After pericardiocentesis, patient has been transferred in operating room to cardiac surgeons that found a severe damage on superior vena cava that they repaired.
Additional Manufacturer Narrative
Blank fields on this form indicated the information is unknown, unchanged, or unavailable.The udi information per 21cfr 803.52(c)(4) and 21 cfr 803.50(b) that is required is reasonably unknown due to the device itself was discarded/not returned for investigation after manufacturer requested for the return.E3 - occupation: doctor.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.
Additional Manufacturer Narrative
Blank fields on this form indicated the information is unknown, unchanged, or unavailable.The udi information per 21cfr 803.52(c)(4) and 21 cfr 803.50(b) that is required is reasonably unknown due to the device itself was discarded/not returned for investigation after manufacturer requested for the return.The lot of the device was known.E1- customer (person): (b)(6) dr.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 is acknowledged, but could not be confirmed, other than by the customer's testimony.The complaint/event that was entered and reported within trackwise: "after the surgery the user said that the blood could have come from the vena and could have been caused by our product." the device history record (dhr) was reviewed.There were no signs that the device was nonconforming or 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
After the procedure, the patient had to undergo surgery because of a blood hemorrhage.After the surgery the user said that the blood could have come from the vena and could have been caused by our product.Once extracted atrial pacemaker without any problem during fibrolisis with evolution 11.0 long shaft, it occurred hemorrhage (pericardial tamponade).After pericardiocentesis, patient has been transferred in operating room to cardiac surgeons that found a severe damage on superior vena cava that they repaired.

• Brand Name: LEAD EXTRACTION EVOLUTION 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: 20339377
• Report Number: 2522007-2024-00037
• Device Sequence Number: 18128902
• Product Code: DRE
• UDI-Device Identifier: 10827002237466
• UDI-Public: (01)10827002237466(17)270331(10)N203943
• 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): 11/20/2024

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
• Operator of Device: Health Professional
• Device Model Number: G23746
• Device Catalogue Number: LR-EVN-11.0-RL
• Device Lot Number: N203943
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2024
• 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-EVN-SH-11.0-RL; LR-EVN-SH-11.0-RL; LR-OFA01; LR-OFA01; LR-OTE-N; LR-OTE-N; LR-TSS-11.0; LR-TSS-11.0; LR-TSS-SH-11.0; LR-TSS-SH-11.0
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 60 KG