LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET
Report
- Report Number
- 2522007-2024-00010
- Event Type
- Injury
- Date Received
- March 13, 2024
- Report Date
- August 29, 2024
- Manufacturer
- COOK VANDERGRIFT INC
- Product Code
- DRB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CORRECTED/UPDATED DATA (B)(6) 2024 AHE PER THE FOLLOWING D4 - UDI: 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 A LITERATURE COMPLAINT AND THE LOT OF THE DEVICE WAS UNKNOWN, RA#: "(B)(4)" (TO REFLECT THE PARENT PR), D2A - COMMON NAME: "DRB STYLET, CATHETER", D2B - PRODUCT CODE: "DRB", D4 MODEL: "G26550" HAS BEEN ADDED/UPDATED TO THIS REPORT. G5 ¿ PMA/510(K): K170298. THE DEVICE WAS NOT RETURNED FOR THE COMPLAINT; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED, AND THE CUSTOMER'S COMPLAINT COULD NOT BE CONFIRMED, OTHER THAN BY THE CUSTOMER'S TESTIMONY. THE COMPLAINT/EVENT THAT WAS ENTERED AND REPORTED WITHIN TRACKWISE: "MAJOR COMPLICATION - PERICARDIAL EFFUSION." PER LITERATURE, IT WAS STATED THAT THERE WERE "TEN PERICARDIAL EFFUSION REQUIRING INTERVENTION." THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE VIEWED DUE TO THE LOT NUMBER SPECIFIC TO THIS COMPLAINT WAS UNKNOWN. 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.
THE DEVICE WAS NOT RETURNED FOR THE COMPLAINT; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED, AND THE CUSTOMER'S COMPLAINT COULD NOT BE CONFIRMED, OTHER THAN BY THE CUSTOMER'S TESTIMONY. THE COMPLAINT/EVENT THAT WAS ENTERED AND REPORTED WITHIN TRACKWISE: "MAJOR COMPLICATION - PERICARDIAL EFFUSION." PER LITERATURE, IT WAS STATED THAT THERE WERE "TEN PERICARDIAL EFFUSION REQUIRING INTERVENTION." THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE VIEWED DUE TO THE LOT NUMBER SPECIFIC TO THIS COMPLAINT WAS UNKNOWN. 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. G5 ¿ PMA/510(K): K170298. 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.
BLANK FIELDS ON THIS FORM INDICATED THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. 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. G5 ¿ PMA/510(K): K170298 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.
PERICARDIAL EFFUSION REQUIRING INTERVENTION (B)(4). LITERATURE - COMPLETE PROCEDURAL SUCCESS WAS ACHIEVED IN (B)(4)) AND CLINICAL SUCCESS IN (B)(4). ALL TARGETED LEADS WERE EXTRACTED IN (B)(4). IN (B)(4)), A SMALL PART OF THE LEAD (<4 CM) WAS LEFT IN PLACE. FAILURE OF THE PROCEDURE OCCURRED IN (B)(4). THE CRUCIAL CAUSE OF PROCEDURAL AND CLINICAL FAILURE WAS THE PRESENCE OF LEAD FRAGMENTS (>4 CM) IN (B)(4). THERE WERE SIGNIFICANT DIFFERENCES BETWEEN CIED INFECTION AND NON¿CIED INFECTION PATIENTS IN ACHIEVING CLINICAL SUCCESS ((B)(4); P 5 .02) AND COMPLETE PROCEDURAL SUCCESS ((B)(4); 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 (B)(4), WHICH OCCURRED SIGNIFICANTLY MORE OFTEN IN NON¿CIED INFECTION PATIENTS ((B)(4); P 5 .02). (B)(4) CASES OF PERICARDIAL EFFUSION WITH NO NEED FOR INTERVENTION OCCURRED IN NON¿CIED INFECTION PATIENTS AND NONE IN THE CIED INFECTION GROUP. (B)(4) PATIENTS DIED UP TO 30 DAYS AFTER THE PROCEDURE, (B)(4) IN THE CIED INFECTION GROUP AND (B)(4) IN NON¿CIED INFECTION ((B)(4)). (B)(4) PATIENTS WITH NON¿CIED INFECTION INDICATIONS FOR TLE WITH RIGHT VENTRICULAR LEAD DYSFUNCTION RESULTING IN ABNORMALITIES OF IMPEDANCE AND CAPTURE AND (B)(4) PATIENTS WITH ISOLATED POCKET EROSION WITH PURULENT DRAINAGE DIED DURING THE PROCEDURE BECAUSE OF SUPERIOR VENA CAVA INJURY ((B)(4)]). THE DWELL TIME OF THOSE EXTRACTED LEADS WAS >10YEARS. (B)(4) 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 (B)(4) PATIENTS. THE FREQUENCY OF OCCURRENCE DID NOT DIFFER BETWEEN THE(B)(4)) (TABLE 4).
PERICARDIAL EFFUSION REQUIRING INTERVENTION (10 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).
PERICARDIAL EFFUSION REQUIRING INTERVENTION (10 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).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 179334 | LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET | DRB STYLET, CATHETER | DRB | COOK VANDERGRIFT INC | G26550 | ||
| 956306 | LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET | DRB STYLET, CATHETER | DRB | COOK VANDERGRIFT INC | G26550 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |