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 Code	Great Vessel Perforation (2152)
Date of Event	05/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicated the information is unknown, unchanged, or unavailable.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
Superior vena cava (svc) was injured during the procedure.As per cc form: transvenous lead extraction (tle) of 10 years old st.Jude leads.Isolation was already damaged in the pocket.Passage through the subclavian vein was very difficult because of strong calcifications under the clavicular bone.Both leads sticking together and had strong adhesions at the svc even at the vena anonyma.After soft traction lead bundle jumped up and atrial lead scratched the svc with an in-consequence ca 5 mm tear and moderate bleeding into the mediastinum.After blocking the svc different short times the bleeding stopped and an implantable cardioverter-defibrillator (icd) lead is implanted.After a following control under computed tomography (ct) a small bleeding is detected and patient is transferred to a heart surgery department of (b)(6)hospital.
Event or Problem Description
Superior vena cava (svc) was injured during the procedure.As per cc form: transvenous lead extraction (tle) of 10 years old st.Jude leads.Isolation was already damaged in the pocket.Passage through the subclavian vein was very difficult because of strong calcifications under the clavicular bone.Both leads sticking together and had strong adhesions at the superior vena cava (svc) even at the vena anonyma.After soft traction lead bundle jumped up and atrial lead scratched the svc with an in-consequence ca 5 mm tear and moderate bleeding into the mediastinum.After blocking the svc different short times the bleeding stopped and an implantable cardioverter-defibrillator (icd) lead is implanted.After a following control under computed tomography (ct) a small bleeding is detected and patient is transferred to a heart surgery dept.Of (b)(6) hospital.
Additional Manufacturer Narrative
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 testimony.The complaint/event entered within trackwise: "svc was injured during the procedure." per complaint: " transvenous lead extraction (tle) of 10 years old st.Jude leads.Isolation was already damaged in the pocket.Passage through the subclavian vein was very difficult because of strong calcifications under the clavicular bone.Both leads sticking together and had strong adhesions at the superior vena cava (svc) even at the vena anonyma.After soft traction lead bundle jumped up and atrial lead scratched the svc with an in-consequence ca 5 mm tear and moderate bleeding into the mediastinum.After blocking the svc different short times the bleeding stopped and a implantable cardioverter defibrillator (icd) lead is implanted.After a following control under computerized tomography (ct) a small bleeding is detected and patient is transferred to a heart surgery department of next university hospital." 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
Superior vena cava (svc) was injured during the procedure.As per cc form: transvenous lead extraction (tle) of 10 years old st.Jude leads.Isolation was already damaged in the pocket.Passage through the subclavian vein was very difficult because of strong calcifications under the clavicular bone.Both leads sticking together and had strong adhesions at the superior vena cava (svc) even at the vena anonyma.After soft traction lead bundle jumped up and atrial lead scratched the svc with an in-consequence ca 5 mm tear and moderate bleeding into the mediastinum.After blocking the svc different short times the bleeding stopped and an implantable cardioverter-defibrillator (icd) lead is implanted.After a following control under computed tomography (ct) a small bleeding is detected and patient is transferred to a heart surgery dept.Of (b)(6) hospital.
Additional Manufacturer Narrative
Blank fields on this form indicated the information is unknown, unchanged, or unavailable.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 testimony.The complaint/event entered within trackwise: "svc was injured during the procedure." per complaint: " transvenous lead extraction (tle) of 10 years old st.Jude leads.Isolation was already damaged in the pocket.Passage through the subclavian vein was very difficult because of strong calcifications under the clavicular bone.Both leads sticking together and had strong adhesions at the superior vena cava (svc) even at the vena anonyma.After soft traction lead bundle jumped up and atrial lead scratched the svc with an in-consequence ca 5 mm tear and moderate bleeding into the mediastinum.After blocking the svc different short times the bleeding stopped and a implantable cardioverter defibrillator (icd) lead is implanted.After a following control under computerized tomography (ct) a small bleeding is detected and patient is transferred to a heart surgery department of next university hospital." 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.

• 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: 17163557
• Report Number: 2522007-2023-00006
• Device Sequence Number: 5745242
• Product Code: DRE
• UDI-Device Identifier: 10827002237466
• UDI-Public: (01)10827002237466(17)251031(10)N192100
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 08/16/2023

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: 10/31/2025
• Device Model Number: G23746
• Device Catalogue Number: LR-EVN-11.0-RL
• Device Lot Number: N192100
• 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; Not provided
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 08/16/2023; 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male