LEAD EXTRACTION BYRD POLYPROPYLENE DILATOR SHEATH SET
Report
- Report Number
- 2522007-2022-00009
- Event Type
- Malfunction
- Date Received
- March 9, 2022
- Report Date
- June 8, 2022
- Manufacturer
- COOK VANDERGRIFT INC
- Product Code
- GCC
- PMA / PMN Number
- K893480
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- 003
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. COMMON NAME: DILATOR, CATHETER. PRODUCT CODE: GCC. PMA/510(K): K893480. 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.
D2 - COMMON NAME: DILATOR, CATHETER. D2B ¿ PRODUCT CODE: GCC. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. NO DEVICES WERE RETURNED ON THIS COMPLAINT, THEREFORE A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED AND THE CUSTOMER'S COMPLAINT COULD NOT BE CONFIRMED BY OTHER THAN THE CUSTOMER'S / LITERATURE TESTIMONY. THE COMPLAINT/EVENT THAT WAS ENTERED AND REPORTED WITHIN TRACKWISE: "TECHNICAL PROBLEMS WERE REPORTED RELATED TO BYRD DILATOR SHEATHS." PER COMPLAINT/LITERATURE: "FROM THREE DIFFERENT PUBLICATIONS OF RETROSPECTIVE DATA COLLECTIONS RELATED TO TRANSVENOUS LEAD EXTRACTIONS, A LARGE NUMBER OF DEVICE-RELATED FAILURES DESCRIBED AS ¿TECHNICAL PROBLEMS¿ WERE REPORTED RELATED TO BYRD DILATOR SHEATHS. CZAJKOWSKI 2021 (ABSTRACT) RETROSPECTIVE ANALYSIS OF VENOGRAMS FROM 2909 PATIENTS WHO UNDERWENT TRANSVENOUS LEAD EXTRACTION BETWEEN 2008 AND 2021 AT A HIGH-VOLUME CENTER. (PAGE 8, TABLE 3) DEVICE-RELATED ISSUES WERE DESCRIBED AS ¿BYRD DILATOR COLLAPSE/TORSION/FRACTURE.¿ STEFANCZYK 2021. (ABSTRACT) TOTAL OF 1000 CONSECUTIVE PATIENTS UNDERGOING TRANSVENOUS LEAD EXTRACTION IN A SINGLE HIGH-VOLUME CENTER FROM 2016 TO 2019 WERE STUDIED. (PAGE 451, TABLE 3) DEVICE-RELATED ISSUES WERE DESCRIBED AS ¿BYRD DILATOR COLLAPSE/TWIST.¿ TULECKI 2021 (PAGE 2) ¿POST-HOC ANALYSIS OF THE CLINICAL DATA OF 1500 PATIENTS UNDERGOING TRANSVENOUS LEAD EXTRACTION AT TWO HIGH-VOLUME CENTERS BETWEEN JUNE 2015 AND APRIL 2021.¿ (PAGE 6) ¿BYRD DILATOR TORSION/COLLAPSE IS MORE FREQUENT IF VENTRICULAR LEADS ARE EXTRACTED, WHICH IS EASY TO EXPLAIN BY THE ANATOMY (BEND) AND EXTRACTED LEAD ROUTE.¿ (PAGE 8, TABLE 4) DEVICE-RELATED ISSUES WERE DESCRIBED AS ¿BYRD DILATOR TORSION/COLLAPSE.¿ ALL PUBLICATIONS ARE RETROSPECTIVE REVIEWS OF PATIENT DATA ACROSS MULTIPLE YEARS. ALL PUBLICATIONS SHARE SEVERAL AUTHORS IN COMMON AND HAVE IDENTICAL CORRESPONDING AUTHORS AND CORRESPONDING AUTHOR INSTITUTIONAL AFFILIATIONS; THUS, IT IS POSSIBLE THE PATIENTS AND DEVICE-RELATED ADVERSE EVENTS IN THE VARIOUS PUBLICATIONS ARE DESCRIBING THE SAME EVENTS. DEVICE ISSUES (FAILURES) WERE DESCRIBED RELATED TO THE BYRD DILATOR SHEATHS AS FOLLOWS: FOR CZAJKOWSKI ET AL, TABLE 3 CONTAINS A LIST OF TECHNICAL PROBLEMS THAT OCCURRED DURING LEAD EXTRACTION PROCEDURES. LINE 11 OF THE TABLE IS TITLED ¿BYRD DILATOR COLLAPSE/TORSION/ FRACTURE¿. A TOTAL OF 96 PATIENTS (3.3% OF THE OVERALL PATIENT POPULATION) EXPERIENCED AT LEAST ONE OF THE ISSUES DESCRIBED WITH THE BYRD DILATORS. FOR STEFANCZYK ET AL, TABLE 3 ALSO CONTAINS A LIST OF TECHNICAL PROBLEMS THAT OCCURRED DURING LEAD EXTRACTION PROCEDURES. THE THIRD LINE UNDER THE ¿PROCEDURE COMPLEXITY - TECHNICAL PROBLEMS¿ SUBHEADING IS TITLED ¿BYRD DILATOR COLLAPSE/TWIST.¿ A TOTAL OF 52 PATIENTS (5.2% OF THE OVERALL PATIENT POPULATION) EXPERIENCED AT LEAST ONE OF THE ISSUES DESCRIBED WITH THE BYRD DILATORS. FOR TULECKI ET AL, TABLE 4 CONTAINS A LIST OF TECHNICAL PROBLEMS THAT OCCURRED DURING LEAD EXTRACTION PROCEDURES. THE FOURTH LINE UNDER THE ¿TECHNICAL PROBLEM DURING TLE (ANY)¿ SUBHEADING IS TITLED ¿BYRD DILATOR TORSION/COLLAPSE.¿ A TOTAL OF 73 PATIENTS (4.9% OF THE OVERALL PATIENT POPULATION) EXPERIENCED AT LEAST ONE OF THE ISSUES DESCRIBED WITH THE BYRD DILATORS. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE LOT OF THE DEVICE(S) WERE UNKNOWN. THE COMPLAINT WILL BE MONITORED FOR TRENDS PER THE COMPLAINT HANDLING AND THE POST MARKET SURVEILLANCE PROCESSES. A RISK ASSESSMENT WILL BE PERFORMED AND DOCUMENTED IN 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.
THIS INCIDENT REPORT COVERS THREE LITERATURE COMPLAINTS ORIGINATING WITHIN POLAND. THE PUBLICATIONS CONSISTED OF RETROSPECTIVE DATA COLLECTED RELATING TO TRANSVENOUS LEAD EXTRACTIONS (TLE) USING BYRD DILATOR SHEATHS. THE FIRST ARTICLE BY CZAJKOWSKI INCLUDED A RETROSPECTIVE ANALYSIS OF VENOGRAMS FROM 2909 PATIENTS THAT UNDERWENT TRANSVENOUS LEAD EXTRACTION BETWEEN 2008 AND 2021 AT A HIGH-VOLUME CENTER IN POLAND. THE SECOND ARTICLE BY STEFANCZYK ET AL COVERED A TOTAL OF 1000 CONSECUTIVE PATIENTS UNDERGOING TRANSVENOUS LEAD EXTRACTION IN A SINGLE HIGH-VOLUME CENTER FROM 2016 TO 2019. THE THIRD ARTICLE BY TULECKI, 2021 CONSISTED OF ¿POST-HOC ANALYSIS OF THE CLINICAL DATA OF 1500 PATIENTS UNDERGOING TRANSVENOUS LEAD EXTRACTION AT TWO HIGH-VOLUME CENTERS BETWEEN JUNE 2015 AND APRIL 2021". ALL THREE PUBLICATIONS ARE RETROSPECTIVE REVIEWS OF PATIENT DATA ACROSS MULTIPLE YEARS USING THE SAME DATA SET AND USERS. ALL PUBLICATIONS SHARE SEVERAL AUTHORS IN COMMON AND HAVE IDENTICAL CORRESPONDING AUTHORS AND CORRESPONDING AUTHOR INSTITUTIONAL AFFILIATIONS. PATIENTS AND DEVICE-RELATED ADVERSE EVENTS IN THE VARIOUS PUBLICATIONS ARE DESCRIBING THE SAME DATA AND PATIENT POPULATION AMONG THE DIFFERENT ARTICLES. DEVICE ISSUES (FAILURES) WERE DESCRIBED RELATED TO THE BYRD DILATOR SHEATHS AS FOLLOWS: FOR CZAJKOWSKI ET AL, TABLE 3 CONTAINS A LIST OF TECHNICAL PROBLEMS THAT OCCURRED DURING LEAD EXTRACTION PROCEDURES. LINE 11 OF THE TABLE IS TITLED ¿BYRD DILATOR COLLAPSE/TORSION/ FRACTURE¿. A TOTAL OF 96 PATIENTS (3.3% OF THE OVERALL PATIENT POPULATION) EXPERIENCED AT LEAST ONE OF THE ISSUES DESCRIBED WITH THE BYRD DILATORS. FOR STEFANCZYK ET AL, TABLE 3 ALSO CONTAINS A LIST OF TECHNICAL PROBLEMS THAT OCCURRED DURING LEAD EXTRACTION PROCEDURES. THE THIRD LINE UNDER THE ¿PROCEDURE COMPLEXITY - TECHNICAL PROBLEMS¿ SUBHEADING IS TITLED ¿BYRD DILATOR COLLAPSE/TWIST.¿ A TOTAL OF 52 PATIENTS (5.2% OF THE OVERALL PATIENT POPULATION) EXPERIENCED AT LEAST ONE OF THE ISSUES DESCRIBED WITH THE BYRD DILATORS. FOR TULECKI ET AL, TABLE 4 CONTAINS A LIST OF TECHNICAL PROBLEMS THAT OCCURRED DURING LEAD EXTRACTION PROCEDURES. THE FOURTH LINE UNDER THE ¿TECHNICAL PROBLEM DURING TLE (ANY)¿ SUBHEADING IS TITLED ¿BYRD DILATOR TORSION/COLLAPSE.¿ A TOTAL OF 73 PATIENTS (4.9% OF THE OVERALL PATIENT POPULATION) EXPERIENCED AT LEAST ONE OF THE ISSUES DESCRIBED WITH THE BYRD DILATORS. INFORMATION PROVIDED VIA SALES REPRESENTATIVE CONFIRMED THAT REPROCESSING OF SINGLE USE BYRD DILATOR SHEATHS OCCURRED AT HOSPITAL OF COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 167929 | LEAD EXTRACTION BYRD POLYPROPYLENE DILATOR SHEATH SET | GCC | COOK VANDERGRIFT INC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |