VISTASEAL DUAL APPLICATOR
Report
- Report Number
- 2210968-2024-09113
- Event Type
- Malfunction
- Date Received
- August 29, 2024
- Date of Event
- August 1, 2024
- Report Date
- October 29, 2024
- Manufacturer
- ETHICON INC.
- Product Code
- MZM
- PMA / PMN Number
- BK180287
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT # (B)(4). H3 INVESTIGATION SUMMARY- THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT THE VSTAS1 DEVICE WAS RETURNED WITH THE LUER LOCKS BROKEN AND ATTACHED TO THE SYRINGE HOLDER WITH PRE-FILLED SYRINGE EMPTY. DUE TO THE CONDITION OF THE RETUNED DEVICE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE REPORTED INCIDENT. AS PART OF ETHICON¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE EVENT REPORTED WAS CONFIRMED AND IT IS RELATED TO IMPROPER USE OF THE DEVICE. ONE POSSIBLE CAUSE FOR THE DAMAGE FOUND ON THE ADAPTER MAY BE EXCESSIVE EXTERNAL LOAD PLACED ON THE DEVICE. ADDITIONAL INFORMATION: GRIFOLS FINAL LETTER: LNSTITUTO GRIFOLS, S.A. UPON THE RECEPTION OF THE NOTIFIED INCIDENT, IT WAS REQUESTED ADDITIONAL INFORMATION SUCH AS THE EXPERIENCE OF THE USER, THE PRESENCE OF ANY LEAKAGE OBSERVED AT THE CONNECTION, AS WELL AS PICTURES OF THE INVOLVED DEVICE. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: ¿ NO LEAKAGE WAS OBSERVED AT THE LUER LOCKS CONNECTION. ¿ THE USER HAS USED THE PRODUCT FOR OVER TWO YEARS. ¿ THERE ARE NO PICTURES AVAILABLE. THE DEVICE WAS RETURNED FOR EVALUATION. PLEASE NOTE THAT UP TO DATE NO PRODUCT WAS RETURNED. ACCORDING TO OUR STANDARD PROCEDURES, IT WAS INITIATED AN INVESTIGATION FOCUSED ON THE FOLLOWING: A. INVESTIGATION OF THE DUAL APPLICATOR TIP: CONSIDERING THE NATURE OF THE REPORTED INCIDENCE, IT WAS REQUESTED TO ETHICON TO CARRY OUT AN INVESTIGATION OF THE BATCH OF TIPS INVOLVED, AS ETHICON IS THE SUPPLIER OF VISTASEAL DUAL APPLICATOR. THE INVESTIGATION WAS FOCUSED ON REVIEWING THE RESULTS OF BATCH RECORDS FOR THE BATCHES OF TIPS USED. IT IS CONCLUDED THAT ALL THE COMPONENTS PARTS UTILIZED FOR THE INVOLVED BATCHES MET THE ESTABLISHED SPECIFICATIONS WITH NO INCIDENTS RELATED. B. RESULTS OF QUALITY CONTROL PERFORMED AT IG FACILITIES. LNSTITUTO GRIFOLS, S.A. REVIEWED THE RESULTS OF THE QUALITY CONTROLS PERFORMED TO THE INCOMING MATERIALS (TIPS) INVOLVED IN THE NOTIFICATION. A REVIEW OF THE RESULTS RELATED TO THE LUER LOCK FUNCTIONALITY PERFORMED TO INCOMING TIPS KITTED WITH THE INVOLVED BATCH, A04J058631, WAS PERFORMED. THE RESULTS WERE FOUND CORRECT WITHIN SPECIFICATIONS AND NO DEVIATIONS WERE DETECTED. EVEN THOUGH A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED, CONSIDERING THAT THERE WERE NO EVIDENCES DETECTED DURING THE MANUFACTURING PROCESS OF THE TIPS, AND THE RESULTS OF THE INCOMING INSPECTION OF THE TIPS WERE CORRECT, IT CAN BE CONCLUDED THAT THE REPORTED NOTIFICATION IS NOT RELATED TO THE QUALITY OF THE COMPONENTS USED. WE WOULD LIKE TO REMARK THE IMPORTANCE OF FOLLOWING THE LEAFLET INSTRUCTIONS REGARDING THE THAWING OF THE PRODUCT AS WELL AS THE TIP CONNECTION INSTRUCTIONS. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, PART 4 SUBPART B. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # (B)(4). H6 COMPONENT CODE: G07002 - PENDING EVALUATION OF RETURNED DEVICE ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: 1. IS THE USER A NEW USER TO VISTASEAL? IF NOT, HOW MANY TIMES HAVE THEY USED VISTASEAL PRIOR TO THIS EVENT? NO ¿ HAS BEEN A USER OF VISTASEAL FOR OVER 2 YEARS. 2. HOW MANY TIMES HAVE THEY APPLIED THE LAPAROSCOPIC TIP? HUNDREDS. 3. WAS A SALES REPRESENTATIVE PRESENT DURING THE CASE WHEN THE ISSUE WAS EXPERIENCED? NO. 4. WAS ANY LEAKAGE OR PRODUCT SOLUTION OBSERVED AT THE LUER LOCKS CONNECTION? NONE REPORTED. 5. WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE EVENT? NO. 6. ARE THERE PICTURES OF THE DAMAGED DEVICE AVAILABLE? DAMAGED DEVICE WAS RETURNED VIA RETURN SHIPPER KIT. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, PART 4 SUBPART B. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # (B)(4). CORRECTED INFORMATION: H 6. MEDICAL DEVICE PROBLEM CODE. D4: FULL UDI CURRENTLY UNAVAILABLE SINCE THE EXACT LOT OF THE SUSPECTED DEVICE CANNOT BE DETERMINED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE POSSIBLE FINISHED DEVICE LOTS, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION: D4, H4 ¿ THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE FOLLOWING ARE THE POSSIBLE BATCH NUMBERS: BATCH 3378429 MFG DATE: 6/24/2023, EXP DATE: 6/25/2028. BATCH 3374448 MFG DATE: 6/16/2023, EXP DATE: 6/17/2028 . THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, PART 4 SUBPART B. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: D4 ¿ THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE FOLLOWING ARE THE POSSIBLE BATCH NUMBERS: 3374448 AND 3378429. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, PART 4 SUBPART B. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HIATAL HERNIA REPAIR PROCEDURE ON (B)(6) 2024 AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. THE SURGEON ROUTINELY USES THE PRODUCT. UPON PREPARING THE PRODUCT THE SURGICAL TECH SAID THAT THE GRAY LUER LOCKS WERE INCREDIBLY DIFFICULT TO TURN AND COULD NOT TWIST THEM TO COMPLETE LAPAROSCOPIC TIP ASSEMBLY. SURGEON SAID THAT THE DEVICE APPEARED TO BE FUSED TOGETHER AND HAD NEVER SEEN IT BEFORE. THE PROCEDURE WAS DELAYED BY FIVE MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1315801 | VISTASEAL DUAL APPLICATOR | FIBRIN SEALANT PREPARATION DEVICE | MZM | ETHICON INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |