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

Model Number	G23737
Medical Device Problem Codes	Material Too Rigid or Stiff (1544); Failure to Align (2522); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	08/04/2025
Type of Reportable Event	Serious Injury
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 due to the complaint was submitted via the fda medwatch program (mw5177017) and the lot of the device was unknown.D1 - primary udi number: unknown e1 - address: per the fda website (https://www.Fda.Gov/about-fda/contact-fda) this is the address to contact the fda via mail.E3 - occupation: assistant director.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
As reported on the medwatch form: in accordance with title 21 part 803, subpart b, 803.22(b)(2), this letter is to notify and provide you the information philips received on (b)(6) 2025 which reported that during a lead extraction procedure, a pericardiai effusion was observed, and thoracotomy was performed to repair a coronary sinus perforation.The patient survived the procedure.A lead extraction procedure commenced to remove ra, rv, and lv leads due to cied system/pocket infection.The ra and rv leads were prepped with llds and the lv lead was prepped with suture and steel wire to provide traction.The ra and rv leads were removed successfully.Using a spectranetics 12f glidelight advancement could not be made over the calcified subclavian region.Switching to a (b)(6)8.Sf byrd dilator sheath, progress was made to the ra.Next, the glidelight could advance without radiation to ra, and the lv lead broke.Changing to a (b) (6) 9f evolution, and aligning axis to the coronary sinus, the lead separated.After that, switching to a femoral approach and right subclavian approach, a 14f glidelight and ospika snare was used to grasp the conductor wire.The glidelight was advanced without radiation into coronary sinus and reached the ostium of coronary sinus.The conductor wire was pulled into (b)(6) check-flo introducer, which was placed in right subclavian.The 9f evolution was inserted into coronary sinus but could not align to the coronary sinus due to the catheter stiffness, and the blood pressure dropped with each traction.After rotating the 9f evolution several times in the coronary sinus, the lv lead was able to be pulled from the side branch of the coronary sinus.Since it could not be retracted into the 9f evolution, the lv lead was pulled out and completely extracted.After removal, pericardia! fluid was observed.An attempt was made to perform a pericardiocentesis, but echocardiography revealed that the needle was unlikely to reach the left ventricular side of the reservoir due to coronary sinus injury.A thoracotomy was performed, the coronary sinus was repaired, and the patient survived the procedure.Philips (spectranetics) is not the manufacturer nor importer of the (f evolution.The manufacturer of this device is (b)(6).
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the manufacturer's investigation, and to provide additional information that was not submitted in the initial report.G3: date received by manufacturer for initial report was november 3, 2025.This event was submitted through the fda's medwatch program (mw5177017) and the reporter requested to remain confidential.The device (9fr evolution) was not returned for evaluation, and the device history record (dhr) could not be viewed due to the lot number specific to this event was not provided.The customer's event is acknowledged, but could not be confirmed, other than by the customer's testimony.Per the event details, a pericardial effusion was observed, and thoracotomy was performed to repair a coronary sinus perforation.The patient survived the procedure.Although the medical device problem codes on mw5177017 were selected as "material too rigid or stiff" and "failure to align", there was no information provided to indicate that an actual malfunction of the device occurred.The evolution is inherently rigid/stiff; without evaluating the actual device, we are not able to determine if there was an issue with the evolution.This event is being monitored, tracked and trended per the cvi post market surveillance and complaint handling processes.Per the manufacturer's instructions for use: "prior to the procedure, consider the size of the catheter/lead in relation to the size of the lead extraction¿ devices to determine possible incompatibility.", "if excessive scar tissue or calcification prevents safe advancement of sheath(s), consider an alternate approach.", "due to rapidly evolving catheter/lead technology, this device may not be suitable for the removal of all types of catheters/leads.If there are questions or concerns regarding compatibility of this device with particular catheters/leads, contact the catheter/lead manufacturer.", "upon removal from package, inspect the product to ensure no damage has occurred.", "warnings: "when using sheaths, do not insert sheaths over more than one lead at a time.Severe vessel damage, including venous wall laceration requiring surgical repair, may occur.", "catheter/lead removal devices should be used only at institutions with thoracic surgical capabilities.", "catheter/lead removal devices should be used only by physicians knowledgeable in the techniques and devices for catheter/lead removal.", "establish back up pacing as necessary.", "have available an extensive collection of sheaths, lead control devices (locking stylet and lead extender), stylets to unscrew active fixation leads, snares, and accessory equipment.", "when advancing sheaths including the evolution or evolution rl controlled-rotation dilator sheath set, use proper sheath technique and maintain adequate tension on the catheter/lead (via a locking stylet or directly) to avoid damage to vessel walls.", "if excessive scar tissue or calcification prevents safe advancement of sheaths, consider an alternate approach.", "excessive force with sheaths, including the evolution or evolution rl controlled-rotation dilator sheath set used intravascularly may result in damage to the vascular system requiring surgical repair.", "if the catheter/lead breaks, evaluate fragment; retrieve as indicated.", "if hypotension develops, rapidly evaluate; treat as appropriate.", "potential adverse events related to the procedure of intravascular extraction of catheters/leads include (listed in order of increasing potential effect): dislodging or damaging nontargeted catheter/lead, chest wall hematoma, thrombosis, arrhythmias, acute bacteremia, acute hypotension, pneumothorax, stroke, migrating fragment from catheter/object, pulmonary embolism, laceration or tearing of vascular structures or the myocardium, hemopericardium/ pericardial effusion, cardiac tamponade, hemothorax, cardiac arrest, death." 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 CATHETERIZATION
• Manufacturer (Section D): COOK VANDERGRIFT INC.; 1186 montgomery lane; vandergrift
• Manufacturer (Section G): COOK VANDERGRIFT INC.; 1186 montgomery lane; vandergrift PA 15690 6065
• Manufacturer Contact: kimberly platt ; 1186 montgomery lane; vandergrift 15690-6065 ; 7248458621
• MDR Report Key: 23697631
• Report Number: 2522007-2025-00032
• Device Sequence Number: 9193750
• Product Code: DRE
• UDI-Device Identifier: 10827002465395
• UDI-Public: 10827002465395
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K141148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

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: G23737
• Device Catalogue Number: LR-EVN-9.0-RL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 12F GLIDELIGHT; 12FR GLIDELIGHT; 14F GLIDELIGHT; 8.5 BYRD DILATOR SHEATH; BYRD DILATOR SHEATH; CHECK-FLO INTRODUCER; CHECK-FLO INTRODUCER; OSPIKA SNARE; OSPIKA SNARE
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Race: Asian