LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION
Report
- Report Number
- 2522007-2023-00020
- Event Type
- Injury
- Date Received
- October 4, 2023
- Report Date
- January 19, 2024
- Manufacturer
- COOK VANDERGRIFT INC
- Product Code
- DXE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. G5 - PMA/510(K): K961992. THIS WAS A LITERATURE COMPLAINT AND 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: "TRICUSPID VALVE REPLACEMENT." PER LITERATURE, "MINOR COMPLICATIONS OCCURRED IN 11 OF 131 PATIENTS (8.4%) (TABLE 3). MORE THAN HALF OF THESE MINOR COMPLICATIONS WERE AN INCREASE IN THE GRADE OF TRICUSPID REGURGITATION WITHOUT THE NEED FOR IMMEDIATE INTERVENTION. MOST FREQUENTLY, THIS WAS A FINDING REPORTED ON THE INTRAOPERATIVE TRANSESOPHAGEAL ECHOCARDIOGRAM WITHOUT CLINICAL CORRELATION. HOWEVER, 1 PATIENT REQUIRED TRICUSPID VALVE REPLACEMENT 5 YEARS AFTER HIS EXTRACTION PROCEDURE FOR RIGHT HEART FAILURE THAT COULD NOT BE ADEQUATELY MANAGED MEDICALLY." 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.
¿BLANK FIELDS ON THIS FORM INDICATED THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE.¿ , FILL IN THE COMMON NAME/PRODUCT CODE/510K INFORMATION IF NEEDED (SEE EXAMPLE BELOW WHAT WILL BE ENTERED ¿ BE SURE TO CONFIRM SPECIFIC CODES TO THE SPECIFIC PRODUCT THAT IS CALLED OUT WITHIN SECTION D: SUSPECT MEDICAL DEVICE ), ¿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 INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE¿ ¿G5 - PMA/510(K): K961992.
LITERATURE - CLINICAL PROCEDURAL SUCCESS WAS ACHIEVED IN 126 OF 131 PATIENTS (96.2%). COMPLETE EXTRACTION SUCCESS WAS ACHIEVED IN 246 OF 267 TARGETED LEADS (92.1%). NO PATIENT IN OUR SERIES EXPERIENCED VASCULAR INJURY, AND IN PARTICULAR THERE WAS NO TEAR, PERFORATION, OR OTHER APPARENT DAMAGE TO THE SUPERIOR VENA CAVA. FOUR PATIENTS EXPERIENCED A TOTAL OF 5 MAJOR COMPLICATIONS (TABLE 3). THREE PATIENTS DEVELOPED PERICARDIAL EFFUSION REQUIRING DRAINAGE. TWO STROKES OCCURRED DURING OR WITHIN 24 HOURS AFTER THE PROCEDURE. THERE WERE NO PROCEDURAL DEATHS. MINOR COMPLICATIONS OCCURRED IN 11 OF 131 PATIENTS (8.4%) (TABLE 3) MORE THAN HALF OF THESE MINOR COMPLICATIONS WERE AN INCREASE IN THE GRADE OF TRICUSPID REGURGITATION WITHOUT THE NEED FOR IMMEDIATE INTERVENTION. MOST FREQUENTLY, THIS WAS A FINDING REPORTED ON THE INTRAOPERATIVE TRANSESOPHAGEAL ECHOCARDIOGRAM WITHOUT CLINICAL CORRELATION. HOWEVER, 1 PATIENT REQUIRED TRICUSPID VALVE REPLACEMENT 5 YEARS AFTER HIS EXTRACTION PROCEDURE FOR RIGHT HEART FAILURE THAT COULD NOT BE ADEQUATELY MANAGED MEDICALLY.
LITERATURE - CLINICAL PROCEDURAL SUCCESS WAS ACHIEVED IN 126 OF 131 PATIENTS (96.2%). COMPLETE EXTRACTION SUCCESS WAS ACHIEVED IN 246 OF 267 TARGETED LEADS (92.1%). NO PATIENT IN OUR SERIES EXPERIENCED VASCULAR INJURY, AND IN PARTICULAR THERE WAS NO TEAR, PERFORATION, OR OTHER APPARENT DAMAGE TO THE SUPERIOR VENA CAVA. FOUR PATIENTS EXPERIENCED A TOTAL OF 5 MAJOR COMPLICATIONS (TABLE 3). THREE PATIENTS DEVELOPED PERICARDIAL EFFUSION REQUIRING DRAINAGE. TWO STROKES OCCURRED DURING OR WITHIN 24 HOURS AFTER THE PROCEDURE. THERE WERE NO PROCEDURAL DEATHS. MINOR COMPLICATIONS OCCURRED IN 11 OF 131 PATIENTS (8.4%) (TABLE 3) MORE THAN HALF OF THESE MINOR COMPLICATIONS WERE AN INCREASE IN THE GRADE OF TRICUSPID REGURGITATION WITHOUT THE NEED FOR IMMEDIATE INTERVENTION. MOST FREQUENTLY, THIS WAS A FINDING REPORTED ON THE INTRAOPERATIVE TRANSESOPHAGEAL ECHOCARDIOGRAM WITHOUT CLINICAL CORRELATION. HOWEVER, 1 PATIENT REQUIRED TRICUSPID VALVE REPLACEMENT 5 YEARS AFTER HIS EXTRACTION PROCEDURE FOR RIGHT HEART FAILURE THAT COULD NOT BE ADEQUATELY MANAGED MEDICALLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1353709 | LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION | DXE CATHETER, EMBOLECTOMY | DXE | COOK VANDERGRIFT INC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |