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

Model Number	G23746
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	05/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Transvenous lead extraction was performed by subclavian vein approach to extract vdd lead which had been implanted in the left precordium in 2002 and another vdd lead which had been implanted in the right precordium in 2006.The lead extraction from the right precordium was performed first, and it was successfully completed without anything remained.The lead extraction from the left precordium was performed next with using the following devices in the following order; lr-evn-sh-9.0-rl/ n186173 --> lr-evn-11.0-rl/ n181031 + lr-tss-11.0/ n178695 --> glidelight 16fr by philips --> lr-nes002/ n179246 --> osypka snare catheter (forceps type) by hiewa bussan.As the anesthesiologist was performing lead extraction from the left precordium, a transesophageal echocardiogram revealed a pericardial effusion, and cardiac tamponade was suspected.A cardiovascular surgeon immediately opened the chest and inserted a drain.He checked the damaged area and found that the bleeding had stopped.A small dent was found near the auricle of right atrium, which was determined to be the source of the bleeding.The patient was returned to the intensive care unit (icu) with hemostatic tape (tachosil) applied, the surgical incision closed, and the drain connected.It cannot be determined which device was related to the damage since the pericardial effusion was confirmed after all the devices were already used.There have been no adverse effects reported to the patient after she was returned to the icu.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable product code: dre.Pma/5109k: 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.
Event or Problem Description
Transvenous lead extraction was performed by subclavian vein approach to extract vdd lead which had been implanted in the left precordium in 2002 and another vdd lead which had been implanted in the right precordium in 2006.The lead extraction from the right precordium was performed first, and it was successfully completed without anything remained.The lead extraction from the left precordium was performed next with using the following devices in the following order; lr-evn-sh-9.0-rl/ lot #n186173 --> lr-evn-11.0-rl/ lot# n181031 + lr-tss-11.0/ lot# n178695 --> glidelight 16fr by philips --> lr-nes002/ lot# n179246 --> osypka snare catheter (forceps type) by hiewa bussan.As the anesthesiologist was performing lead extraction from the left precordium, a transesophageal echocardiogram revealed a pericardial effusion, and cardiac tamponade was suspected.A cardiovascular surgeon immediately opened the chest and inserted a drain.He checked the damaged area and found that the bleeding had stopped.A small dent was found near the auricle of right atrium, which was determined to be the source of the bleeding.The patient was returned to the intensive care unit (icu) with hemostatic tape (tachosil) applied, the surgical incision closed, and the drain connected.It cannot be determined which device was related to the damage since the pericardial effusion was confirmed after all the devices were already used.There have been no adverse effects reported to the patient after she was returned to the icu.
Additional Manufacturer Narrative
D2b - product code: dre.G4 - pma/5109k: k141148.Investigation - evaluation a device was not returned on this complaint, therefore a physical investigation could not be performed and the customer's complaint could not be confirmed other than by customer's testimony.The complaint/event that was entered and reported into trackwise: "damage near the auricle of the right atrium resulting in open-heart surgery." the complaint information states: "as the anesthesiologist was performing lead extraction from the left precordium, a transesophageal echocardiogram revealed a pericardial effusion, and cardiac tamponade was suspected.A cardiovascular surgeon immediately opened the chest and inserted a drain.He checked the damaged area and found that the bleeding had stopped.A small dent was found near the auricle of right atrium, which was determined to be the source of the bleeding.The patient was returned to the intensive care unit (icu) with hemostatic tape (tachosil) applied, the surgical incision closed, and the drain connected.It cannot be determined which device was related to the damage since the pericardial effusion was confirmed after all the devices were already used.There have been no adverse effects reported to the patient after she was returned to the icu." 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 is being monitored, tracked and trended per the cvi post market surveillance and complaint handling processes.A risk assessment will be performed and documented in the complaint summary tab in 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: VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION
• 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: brian johnston ; 1186 montgomery lane; vandergrift, PA 15690 ; 7248458621
• MDR Report Key: 14547978
• Report Number: 2522007-2022-00015
• Device Sequence Number: 15095236
• Product Code: DRE
• UDI-Device Identifier: 10827002237466
• UDI-Public: (01)10827002237466(17)240630(10)N181031
• 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): 07/20/2022

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: 06/30/2024
• Device Model Number: G23746
• Device Catalogue Number: LR-EVN-11.0-RL
• Device Lot Number: N181031
• 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: 05/31/2022
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2021
• 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: 500-303 / GLIDELIGHT16FR (BY PHILIPS); 500-303/GLIDELIGHT16FR (BY PHILIPS); G23746/LR-EVN-11.0-RL / N181031; G23748 / LR-EVN-SH-9.0-RL / N186173; G23748/LR-EVN-SH-9.0-RL / N186173; G25083 / LR-TSS-11.0 / N178695; G25083/LR-TSS-11.0 / N178695; G26515 / LR-NES002 / N179246; G26515/LR-NES002/ N179246; OSYPKA SNARE CATHETER 5F / 110CM (BYHEIWA BUSSAN); OSYPKA SNARE CATHETER 5F/110CM (BYHEIWA BUSSAN)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female