CANNULA & CATHETER
Report
- Report Number
- 8010762-2025-0000184
- Event Type
- Malfunction
- Date Received
- April 22, 2025
- Date of Event
- April 5, 2025
- Report Date
- August 8, 2025
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DWF
- UDI-DI
- 04058863133812
- PMA / PMN Number
- K081820
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE AFFECTED HLS SET WAS REQUESTED FOR FURTHER INVESTIGATION. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE SWISS MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "AVALON ELITE CANNULA¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K081820. FOR SECTION D4 ALL AVAILABLE IDENTIFYING INFORMATION IS FOR THE OUT OF THE US DEVICE, SUBJECTED TO THIS REPORT. THEREFORE, NO GUDID INFORMATION EXISTS. FURTHERMORE, UDI INFORMATION (PRIMARY DI NUMBER) PROVIDED IN D4 IS FOR AVALON ELITE CANNULA WITH CATALOG NUMBER 701073606.
THE EVENT OCCURRED IN SWITZERLAND. IT WAS REPORTED THAT AT THE BEGINNING OF A PATIENT TREATMENT AFTER INSERTING THE AVALON ELITE CANNULA (20F, 31 CM), THE INTRODUCER COULD NOT BE REMOVED. SINCE THE INTRODUCER WAS STUCK IN THE CANNULA, THE CANNULA WAS REMOVED WITH THE INTRODUCER BY THE OPERATOR. AFTERWARDS, THE SAME ISSUE OCCURRED WITH A SECOND AVALON ELITE CANNULA (20F, 31 CM). THE INTRODUCER COULD NOT BE REMOVED AS WELL. AFTER INSERTING THE THIRD AVALON ELITE CANNULA (23F, 31 CM) THE INTRODUCER COULD BE REMOVED AFTER INSERTION AND THE PATIENT COULD BE TREATED NORMALLY AFTER THIS EVENT. THERE WERE NO PARTICULAR COMPLICATIONS. NO HARM TO ANY PERSON HAS BEEN REPORTED. DUE TO THE DELAY IN TREATMENT AND REPLACEMENTS OF THE CANNULA, THE EVENT CAN RESULT IN A RISK FOR HARM OF ANY PERSON, A REPORT IS REQUIRED. BOTH AFFECTED AVALON ELITE CANNULAS WERE INVESTIGATED IN THE GETINGE LABORATORY ON 2025-08-07 WITH THE FOLLOWING CONCLUSION: "THE REPORTED FAILURE COULD BE CONFIRMED DURING THE INVESTIGATION, THE INTRODUCERS WERE VERY DIFFICULT TO INSERT AND REMOVE ON BOTH CANNULAS. NO DEFINITE ROOT CAUSE COULD BE DETERMINED. HOWEVER, SINCE NO MEASURABLE DEVIATION OF THE CANNULAS DIMENSIONS COULD BE DETECTED NOR AN OUTER DEFORMATION COULD BE INVESTIGATED (FROM THE OUTSIDE), A MOST PROBABLE ROOT CAUSE COULD BE IMPROPER HANDLING (DURING APPLICATION) WHICH CAUSED A NARROW SECTION IN THE CANNULAS BODY." IN ORDER TO AVOID A POSSIBLE REOCCURRENCE OF THE REPORTED EVENT, THE CUSTOMER WILL BE INFORMED BY THE GETINGE SALES AND SERVICE UNIT (SSU) TO FOLLOW THE CHAPTER IN THE INSTRUCTION FOR USE AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER: CHAPTER 5.3: SAFETY INFORMATION FOR CATHETER ¿ DO NOT USE DEFORMED CATHETERS. ¿ DO NOT ATTEMPT TO BEND DEFORMED CATHETERS BACK INTO THEIR ORIGINAL SHAPE. CHAPTER 7: APPLICATION - MOISTEN THE INTRODUCER COMPLETELY WITH PHYSIOLOGICAL SALINE SOLUTION (0.9%) IMMEDIATELY BEFORE USE PRIOR TO INSERTING IT IN THE CATHETER. - INSERT THE INTRODUCER INTO THE DRAINAGE LUMEN OF THE CATHETER AND FULLY ENGAGE THE CAP ONTO THE CONNECTOR. - CHECK THE MOBILITY OF THE INTRODUCER BEFORE USING THE CATHETER. IT MUST BE POSSIBLE TO MOVE THE INTRODUCER FREELY AND WITHOUT HINDRANCE. - WHEN INSERTING THE INTRODUCER INTO THE CATHETER, ENSURE THAT THE LINE MARKING DISAPPEARS COMPLETELY INTO THE CAP. IN THIS WAY, THE MINIMUM INSERTION DEPTH OF THE INTRODUCER IS ACHIEVED. - TO REMOVE THE INTRODUCER, IT MUST NOT BE INSERTED TOO FAR INTO THE CATHETER. OBSERVE THE DEPTH MARKINGS ON THE INTRODUCER DURING INSERTION. - THE CATHETER CAN BE INTRODUCED EITHER INTO THE PREVIOUSLY EXPOSED VESSEL UNDER VISUAL CONTROL ALONG THE GUIDE WIRE OR PERCUTANEOUSLY USING THE SELDINGER TECHNIQUE. THE CHOICE OF INSERTION TECHNIQUE IS AT THE PHYSICIAN'S DISCRETION ON THE BASIS OF HIS OR HER EXPERIENCE. TAKE THE COMPONENTS FOR IMPLEMENTING THE SELDINGER TECHNIQUE FROM THE SEPARATE INSERTION KIT AND OBSERVE THE CORRESPONDING INSTRUCTIONS FOR USE. THE PRODUCTION RECORDS OF THE AFFECTED PRODUCT WERE REVIEWED BY THE CANNULA SUPPLIER, (B)(4), ON 2025-06-09. ACCORDING TO THE FINAL TEST RESULTS, THE PRODUCT PASSED THE TESTS AS PER SPECIFICATIONS. PRODUCTION RELATED INFLUENCES ARE UNLIKELY. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED FOR THE REVIEWED TIME PERIOD. IT DOES NOT SHOW ANY NON-CONFORMITY IN REGARDS TO THE REPORTED PRODUCT AND FAILURE. IN ADDITION, A REVIEW FOR POTENTIAL FIELD ACTIONS AND CAPAS RELATED TO THE FAILURE AND PRODUCT IN THIS COMPLAINT WAS PERFORMED. THIS COMPLAINT IS NOT IN SCOPE OF ANY ONGOING FIELD ACTIONS AND/OR CAPAS. THIS COMPLAINT WAS FOUND IN THE DATABASE OF CUSTOMER COMPLAINTS FOR THE AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER AS A SINGLE EVENT (TIMEFRAME FROM 2024-04-07 TILL 2025-04-07). BASED ON THE RESULTS THE REPORTED FAILURE "INTRODUCER COULD NOT BE REMOVED" COULD BE CONFIRMED. THE CUSTOMER WILL BE INFORMED ABOUT THE RESULTS BY THE GETINGE SALES AND SERVICE UNIT. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED ISSUE AND IT WAS DETERMINED THAT THIS IS NOT A SYSTEMIC ISSUE. THEREFORE, NO REMEDIAL ACTION IS REQUIRED. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY¿ S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING. NOTE: THIS EVENT OCCURRED ON THE SWISS MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "AVALON ELITE CANNULA¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K081820. FOR SECTION D4 ALL AVAILABLE IDENTIFYING INFORMATION IS FOR THE OUT OF THE US DEVICE, SUBJECTED TO THIS REPORT. THEREFORE, NO GUDID INFORMATION EXISTS. FURTHERMORE, UDI INFORMATION (PRIMARY DI NUMBER) PROVIDED IN D4 IS FOR AVALON ELITE CANNULA WITH CATALOG NUMBER 701073606.
THE EVENT OCCURRED IN SWITZERLAND. IT WAS REPORTED THAT AT THE BEGINNING OF A PATIENT TREATMENT AFTER INSERTING THE AVALON ELITE CANNULA (20F, 31 CM), THE INTRODUCER COULD NOT BE REMOVED. SINCE THE INTRODUCER WAS STUCK IN THE CANNULA, THE CANNULA WAS REMOVED WITH THE INTRODUCER BY THE OPERATOR. AFTERWARDS, THE SAME ISSUE OCCURRED WITH A SECOND AVALON ELITE CANNULA (20F, 31 CM). THE INTRODUCER COULD NOT BE REMOVED AS WELL. AFTER INSERTING THE THIRD AVALON ELITE CANNULA (23F, 31 CM) THE INTRODUCER COULD BE REMOVED AFTER INSERTION AND THE PATIENT COULD BE TREATED NORMALLY AFTER THIS EVENT. THERE WERE NO PARTICULAR COMPLICATIONS. NO HARM TO ANY PERSON HAS BEEN REPORTED. DUE TO THE DELAY IN TREATMENT AND SEVERAL REPLACEMENTS OF THE CANNULA, THE EVENT CAN RESULT IN A RISK FOR HARM OF ANY PERSON A REPORT IS REQUIRED. COMPLAINT ID # (B)(4).
COMPLAINT ID # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1015470 | CANNULA & CATHETER | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS | DWF | MAQUET CARDIOPULMONARY GMBH | AVALON ELITE CANNULA & CATHETER | 423009 | 04058863133812 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |