LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
Report
- Report Number
- 2522007-2023-00027
- Event Type
- Injury
- Date Received
- December 20, 2023
- Date of Event
- November 30, 2023
- Report Date
- August 27, 2024
- Manufacturer
- COOK VANDERGRIFT INC
- Product Code
- DRE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
G5 ¿ PMA/510(K): K141148. THE DEVICE WAS DISCARDED AND 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: "A PERICARDIAL EFFUSION OCCURRED REQUIRING AN OPEN REPAIR." PER COMPLAINT: "AS REPORTED TO CUSTOMER RELATIONS VIA PHONE CONVERSATION "AFTER THE CASE THE PATIENT'S BLOOD PRESSURE DROPPED. A PERICARDIAL EFFUSION OCCURRED REQUIRING AN OPEN REPAIR. NOTE: THE EXTRACTION WAS SUCCESSFUL." THE DEVICE HISTORY RECORD (DHR) WAS NOT ABLE TO BE REVIEWED. THE LOT NUMBER FOR THIS COMPLAINT DEVICE WAS UNKNOWN. THIS COMPLAINT MODE WILL BE TRACKED, TRENDED AND MONITORED IN CVI COMPLAINT HANDLING AND POST MARKET SURVEILLANCE PROCEDURES. A RISK ASSESSMENT WILL BE PERFORMED WITHIN 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.
CORRECTED DATA ON 16JUL2024 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 AFTER MANUFACTURER REQUESTED FOR THE RETURN AND THE LOT OR THE DEVICE WAS UNKNOWN." HAS BEEN ADDED/UPDATED TO THIS REPORT. G5 ¿ PMA/510(K): K141148 . THE DEVICE WAS DISCARDED AND 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: "A PERICARDIAL EFFUSION OCCURRED REQUIRING AN OPEN REPAIR." PER COMPLAINT: "AS REPORTED TO CUSTOMER RELATIONS VIA PHONE CONVERSATION "AFTER THE CASE THE PATIENT'S BLOOD PRESSURE DROPPED. A PERICARDIAL EFFUSION OCCURRED REQUIRING AN OPEN REPAIR. NOTE: THE EXTRACTION WAS SUCCESSFUL." THE DEVICE HISTORY RECORD (DHR) WAS NOT ABLE TO BE REVIEWED. THE LOT NUMBER FOR THIS COMPLAINT DEVICE WAS UNKNOWN. THIS COMPLAINT MODE WILL BE TRACKED, TRENDED AND MONITORED IN CVI COMPLAINT HANDLING AND POST MARKET SURVEILLANCE PROCEDURES. A RISK ASSESSMENT WILL BE PERFORMED WITHIN 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.
CORRECTED/UPDATED DATA 27AUG2024 AHE PER THE FOLLOWING D4 - UDI: THE UDI INFORMATION PER 21CFR 803.52(C)(4) AND 21 CFR 803.50(B) THAT IS REQUIRED HAS BEEN ADDED/UPDATED TO THIS REPORT: D4 MODEL: G23746. H10 HAS BEEN ADDED/UPDATED WITH "E3 - OCCUPATION: UNKNOWN TITLE.". G5 ¿ PMA/510(K): K141148. THE DEVICE WAS DISCARDED AND 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: "A PERICARDIAL EFFUSION OCCURRED REQUIRING AN OPEN REPAIR." PER COMPLAINT: "AS REPORTED TO CUSTOMER RELATIONS VIA PHONE CONVERSATION "AFTER THE CASE THE PATIENT'S BLOOD PRESSURE DROPPED. A PERICARDIAL EFFUSION OCCURRED REQUIRING AN OPEN REPAIR. NOTE: THE EXTRACTION WAS SUCCESSFUL." THE DEVICE HISTORY RECORD (DHR) WAS NOT ABLE TO BE REVIEWED. THE LOT NUMBER FOR THIS COMPLAINT DEVICE WAS UNKNOWN. THIS COMPLAINT MODE WILL BE TRACKED, TRENDED AND MONITORED IN CVI COMPLAINT HANDLING AND POST MARKET SURVEILLANCE PROCEDURES. A RISK ASSESSMENT WILL BE PERFORMED WITHIN 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.
G5 ¿ PMA/510(K): K141148. 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.
AS REPORTED TO CUSTOMER RELATIONS VIA PHONE CONVERSATION "AFTER THE CASE THE PATIENT'S BLOOD PRESSURE DROPPED. A PERICARDIAL EFFUSION OCCURRED REQUIRING AN OPEN REPAIR." NOTE: THE EXTRACTION WAS SUCCESSFUL.
AS REPORTED TO CUSTOMER RELATIONS VIA PHONE CONVERSATION "AFTER THE CASE THE PATIENT'S BLOOD PRESSURE DROPPED. A PERICARDIAL EFFUSION OCCURRED REQUIRING AN OPEN REPAIR. NOTE: THE EXTRACTION WAS SUCCESSFUL.
AS REPORTED TO CUSTOMER RELATIONS VIA PHONE CONVERSATION "AFTER THE CASE THE PATIENT'S BLOOD PRESSURE DROPPED. A PERICARDIAL EFFUSION OCCURRED REQUIRING AN OPEN REPAIR. NOTE: THE EXTRACTION WAS SUCCESSFUL.
AS REPORTED TO CUSTOMER RELATIONS VIA PHONE CONVERSATION "AFTER THE CASE THE PATIENT'S BLOOD PRESSURE DROPPED. A PERICARDIAL EFFUSION OCCURRED REQUIRING AN OPEN REPAIR. NOTE: THE EXTRACTION WAS SUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2110783 | LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET | DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHERIZATION | DRE | COOK VANDERGRIFT INC | G23746 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Other |