CELT ACD VASCULAR CLOSURE DEVICE
Report
- Report Number
- 3009984513-2024-00011
- Event Type
- Malfunction
- Date Received
- July 30, 2024
- Report Date
- September 18, 2024
- Manufacturer
- VASORUM LTD.
- Product Code
- MGB
- UDI-DI
- 05391530280006
- PMA / PMN Number
- P150006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WERE NO REPORTED HEALTH CONSEQUENCES OR IMPACT FOR THE PATIENT ASSOCIATED TO THIS EVENT. A SEARCH OF THE COMPLAINT'S FILES IDENTIFIED ONE OTHER REPORT WITH THE SAME LOT NUMBER ASSOCIATED WITH A PREVIOUS MDR (2024-00010). DEVICES ARE BEING RETURNED TO VASORUM LTD. FOR EXAMINATION. A REVIEW OF THE LOT RECORDS DID NOT IDENTIFY ANY NON-CONFORMANCES OR ISSUES DURING THE PRODUCTION OF THIS PARTICULAR LOT. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN THE CUSTOMER COMPLAINT FILES OF VASORUM LTD FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. THIS REPORT IS THE INITIAL REPORT BEING SUBMITTED BY VASORUM LTD.
DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WERE NO REPORTED HEALTH CONSEQUENCES OR IMPACT FOR THE PATIENT ASSOCIATED TO THIS EVENT. A SEARCH OF THE COMPLAINT'S FILES FOUND 1 OTHER REPORT WITH THE SAME LOT NUMBER (2024-00010). DEVICES HAVE BEEN RETURNED TO VASORUM LTD. FOR EXAMINATION. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW AND THE TESTING AND EVALUATION OF THE RETURNED DEVICE, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE ISSUE REPORTED. NEITHER THE DEVICE ANALYSIS, NOR THE INFORMATION AVAILABLE FOR REVIEW SUGGEST THAT THE REPORTED EVENT COULD BE RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE UNIT. NO FAULTS WERE IDENTIFIED DURING THE TEST PROCESS. THE 5F CORDIS AVANTI SHEATH DEMONSTRATED ADEQUATE PERFORMANCE FOR THE 5F CELT DEVICES, WITH LITTLE TO NO RESISTANCE OBSERVED. A REVIEW OF THE LOT RECORDS DID NOT IDENTIFY ANY NON-CONFORMANCES OR ISSUES DURING THE PRODUCTION OF THIS PARTICULAR LOT. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN THE CUSTOMER COMPLAINT FILES OF VASORUM LTD FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. NO CORRECTIVE/PREVENTATIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS REPORT IS THE FINAL REPORT BEING SUBMITTED BY VASORUM LTD UNLESS REQUESTED BY THE FDA. INVESTIGATION FINDINGS CODE 4247 WAS USED AS NO OTHER FEASIBLE CODE WAS FOUND FOR THE PREFERRED TERM "INCONCLUSIVE". INVESTIGATION CONCLUSIONS CODE 4316 WAS USED AS NO OTHER FEASIBLE CODE WAS FOUND FOR THE PREFERRED TERM "INCONCLUSIVE".
IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ON MULTIPLE OCCASIONS TO INSERT 5F CELT DEVICES INTO 5F CORDIS AVANTI SHEATHS. IN EACH SITUATION, THE PHYSICIAN REPORTED EXPERIENCING EXCESSIVE RESISTANCE DURING INSERTION AND WAS UNABLE TO ADVANCE THE DELIVERY SYSTEM COMPLETELY INTO THE SHEATH. IN EACH SITUATION, A NEW 5F CELT WAS USED WITH A DIFFERENT LOT NUMBER AND THE CLOSURE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. DEVICES ARE BEING RETURNED TO VASORUM LTD FOR INSPECTION.
IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ON MULTIPLE OCCASIONS TO INSERT 5F CELT DEVICES INTO 5F CORDIS AVANTI SHEATHS. IN EACH SITUATION, THE PHYSICIAN REPORTED EXPERIENCING EXCESSIVE RESISTANCE DURING INSERTION AND WAS UNABLE TO ADVANCE THE DELIVERY SYSTEM COMPLETELY INTO THE SHEATH. IN EACH SITUATION, A NEW 5F CELT WAS USED WITH A DIFFERENT LOT NUMBER AND THE CLOSURE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. DEVICES ARE BEING RETURNED TO VASORUM LTD FOR INSPECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 243987 | CELT ACD VASCULAR CLOSURE DEVICE | VASCULAR CLOSURE DEVICE | MGB | VASORUM LTD. | KCLT-05 | 942889 | 05391530280006 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |