MAUDE Adverse Event Report: COOK VANDERGRIFT INC LEAD EXTRACTION BYRD POLYPROPYLENE DILATOR SHEATH SET; GCC DILATOR, CATHETER

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 02/14/2024

Event Type  Injury  

Event Description

Vascular laceration (7 patients).Literature - complete procedural success was achieved in 474 patients (94.0%) and clinical success in 492 (97.6%).All targeted leads were extracted in 478 patients (94.8%).In 14 patients (2.8%), a small part of the lead (<4 cm) was left in place.Failure of the procedure occurred in 30 patients (6.0%).The crucial cause of procedural and clinical failure was the presence of lead fragments (>4 cm) in 12 patients (2.4%).There were significant differences between cied infection and non¿cied infection patients in achieving clinical success (99.3% vs 96.6%; p 5.02) and complete procedural success (97.4% vs 92.6%; p 5.04).Three patients from the cied infection group underwent gladysz-wa_nha et al lead extraction in patients with and without infections 3 incomplete lead extraction (<4 cm of the lead left in place), which had no negative impact on the course of the infection (figure 2).The most frequent minor complication was venous thrombosis in 19 patients (3.8%), which occurred significantly more often in non¿cied infection patients (5.1% vs 0.7%; p 5.02).Four cases of pericardial effusion with no need for intervention occurred in non¿cied infection patients and none in the cied infection group.Twelve patients died up to 30 days after the procedure, 10 in the cied infection group and 2 in non¿cied infection (p 5.0001).Two patients with non¿cied infection indications for tle with right ventricular lead dysfunction resulting in abnormalities of impedance and capture and 1 patients with isolated pocket erosion with purulent drainage died during the procedure because of superior vena cava injury (n 5 3 [0.6%]).The dwell time of those extracted leads was >10years.Nine patients (1.8%) died up to 30 days after the procedure because of postoperative management issues of underlying diseases (eg, sepsis or heart failure).The most frequent major complication, excluding death, was pericardial effusion requiring open heart surgery in 10 patients.The frequency of occurrence did not differ between the 2 groups (p 5.16) (table 4).

Manufacturer Narrative

Blank fields on this form indicated the information is unknown, unchanged, or unavailable.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.

• Brand Name: LEAD EXTRACTION BYRD POLYPROPYLENE DILATOR SHEATH SET
• Type of Device: GCC DILATOR, CATHETER
• 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: 18902152
• MDR Text Key: 337632429
• Report Number: 2522007-2024-00007
• Device Sequence Number: 1
• Product Code: GCC
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K893480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention