MAUDE Adverse Event Report: COOK VANDERGRIFT INC LEAD EXTRACTION STEADYSHEATH¿ EVOLUTION® TISSUE STABILIZATION SHEATH; DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHERIZATION

Model Number	G25083
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate 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.
Event or Problem Description
Medical history: unknown.Infectious disease: yes, but details unknown.Approach via left subclavian vein, planning to use it for rv lead.When lr-tss-11.0 was set on evolution11fr and used in front of svc to detach the adhesion of ra lead, the detachment did not proceed.Therefore, the physician attempted to remove the evolution11fr and the product in question, the stainless steel tip of the product came off.Since there was a possibility that the stainless steel tip might fly to other parts of the body if the lr-tss-11.0 was removed as it was, a sheath for medtronic micra was inserted through the femoral vein and the tip of the ra lead was retracted.The evolution 11fr and lr-tss-11.0 were also inserted into the micra sheath to prevent the stainless steel tip from flying off, and a guide wire was passed through the evolution 11fr and a valve was inserted through the femoral vein.The balloon was passed though the stainless steel tip and inflated, the stainless steel tip was fixed with the balloon, and then removed from the femoral vein.After the additional procedure, the patient was no problems.Physician's comment obtained by a sales rep from a distributor : the tip was removed without the appearance of exerting much force.This was the first time this had happened.
Additional Manufacturer Narrative
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 and the lot of the device was unknown, however the device was returned, and the lot was known.G5 ¿ pma/510(k): k141148.One lr-tss-11.0 was returned along with a separated stainless-steel tip.(it was two separate parts.) the complaint / event that was entered and reported within trackwise: "a stainless steel distal tip was come off." the quality assurance department and engineering performed an investigation and evaluation on the returned device.The sheath and tip were investigated under increased magnification using a microscope/computer inspection station.They were visually inspected.Visually the device had blood present throughout the device including small chunks within the sheath.The device showed there was adhesive present on the stainless-steel tip.The sheath was investigated internally and cut open by the engineers, which it was noted that on the inner side of the sheath showed some sort of gouging approximately 3mm of the inner sheath.It is uncertain at this time the cause, but the customer's complaint was indeed confirmed that the stainless-steel tip did come off and showing the device was used.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 complaint is associated with internal investigation request, (b)(4).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
Medical history: unknown.Infectious disease: yes, but details unknown.Approach via left subclavian vein, planning to use it for rv lead.When lr-tss-11.0 was set on evolution 11fr and used in front of svc to detach the adhesion of ra lead, the detachment did not proceed.Therefore, the physician attempted to remove the evolution 11fr and the product in question, the stainless-steel tip of the product came off.Since there was a possibility that the stainless-steel tip might fly to other parts of the body if the lr-tss-11.0 was removed as it was, a sheath for medtronic micra was inserted through the femoral vein and the tip of the ra lead was retracted.The evolution 11fr and lr-tss-11.0 were also inserted into the micra sheath to prevent the stainless-steel tip from flying off, and a guide wire was passed through the evolution 11fr and a valve was inserted through the femoral vein.The balloon was passed though the stainless-steel tip and inflated, the stainless-steel tip was fixed with the balloon, and then removed from the femoral vein.After the additional procedure, the patient was no problems.Physician's comment obtained by a sales rep from a distributor: the tip was removed without the appearance of exerting much force.This was the first time this had happened.

• Brand Name: LEAD EXTRACTION STEADYSHEATH¿ EVOLUTION® TISSUE STABILIZATION SHEATH
• 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: 20184749
• Report Number: 2522007-2024-00031
• Device Sequence Number: 21065555
• Product Code: DRE
• UDI-Device Identifier: 00827002250833
• UDI-Public: (01)00827002250833(17)270228(10)N202549
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G25083
• Device Catalogue Number: LR-TSS-11.0
• Device Lot Number: N202549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/19/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2024
• 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-11.0RL.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown