INDEFLATOR
Report
- Report Number
- 2024168-2024-02437
- Event Type
- Malfunction
- Date Received
- February 27, 2024
- Date of Event
- February 7, 2024
- Report Date
- November 12, 2024
- Manufacturer
- ABBOTT VASCULAR INC.
- Product Code
- MAV
- UDI-DI
- 08717648013591
- PMA / PMN Number
- K991102
- Removal / Correction Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED LEAK WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD (DHR) AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT LEVEL PRODUCT QUALITY ISSUE. AS THE REPORTED LEAK WAS UNABLE TO BE CONFIRMED DURING RETURN ANALYSIS, IT IS POSSIBLE THAT THE CONNECTION PORT WAS NOT FULLY CONNECTED/TIGHTENED AND/OR THE DEVICE BEING CONNECTED WAS COMPROMISED THUS RESULTING IN THE REPORTED LEAK DIFFICULTIES; HOWEVER, THIS CANNOT BE CONFIRMED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED LEAK DIFFICULTIES. BASED ON THE REPORTED INFORMATION AND RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. E1 CORRECTION - PHONE NUMBER - UPDATED.
G4: PMA/510(K) # CORRECTION: CORRECTED FROM K961471 TO K991102. H6 CORRECTION: TYPE OF INVESTIGATION: ADDED 4101 (TESTING OF DEVICE FROM SAME LOT/BATCH RETURNED FROM USER). H6 CORRECTION: INVESTIGATION FINDINGS: REMOVED 213 (NO DEVICE PROBLEM FOUND) AND ADDED 170 (MANUFACTURING PROCESS PROBLEM IDENTIFIED). H6 CORRECTION: INVESTIGATION CONCLUSIONS: REMOVED 67 (NO PROBLEM DETECTED) AND ADDED 23 (MANUFACTURING DEFICIENCY). H11 CORRECTION: ADDITIONAL MANUFACTURER NARRATIVE: THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE A POTENTIAL PRODUCT QUALITY ISSUE. ADDITIONALLY, A VISUAL AND DIMENSIONAL INSPECTION WAS PERFORMED ON UNUSED/STERILE UNITS FROM THE SAME PART AND LOT NUMBER. ABNORMALITIES WERE FOUND. ON OCT 24TH 2024, ABBOTT VASCULAR DETERMINED THAT A FIELD ACTION WAS REQUIRED FOR SPECIFIC LOTS OF INDEFLATOR 20/30 PRODUCT. THE PRODUCT ASSOCIATED WITH THIS COMPLAINT IS FROM THE IMPACTED POPULATION. THIS ACTION IS BEING TAKEN DUE TO AN INCREASED POTENTIAL FOR A LEAK IN THE INDEFLATOR UNDER PRESSURE OR VACUUM DUE TO A GAP IN THE HOSE SNAP FITTING AND O-RINGS FROM A SPECIFIC SUPPLIER.
SUBSEQUENT TO FILING THE INITIAL REPORTS, 49 STERILE UNUSED DEVICES WERE RECEIVED WITH LOT NUMBER 60418468. A VISUAL AND FUNCTIONAL ANALYSIS WAS PERFORMED. 26 UNITS WERE RANDOMLY SELECTED. ALL 26 SAMPLES WERE VISUALLY INSPECTED WITH NO ANOMALIES NOTED. ALL 26 SAMPLES UNDERWENT FUNCTIONAL TESTING AND 6 FAILED PRESSURIZAT 2024168-2024-02437-2ION. THE 6 STERILE UNUSED DEVICES WHICH FAILED PRESSURIZATION WILL BE FILED ON SEPARATE MDR REPORTS. ADDITIONALLY, THE 7 ADDITIONAL USED DEVICES RECEIVED AND REFERENCED IN B5 WILL BE FILED ON SEPARATE MDR REPORTS. ADDITIONAL INFORMATION: D4 - MODEL # ADDED CORRECTIONS: D1 - BRAND NAME UPDATED D2A - COMMON DEVICE NAME UPDATED D3 - NAME UPDATED D3 - ADDRESS, CITY, POSTAL CODE UPDATED.
MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL 20/30 PRIORITY PACK INDEFLATOR DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.
THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED LEAK WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD (DHR) AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT LEVEL PRODUCT QUALITY ISSUE. AS THE REPORTED LEAK WAS UNABLE TO BE CONFIRMED DURING RETURN ANALYSIS, IT IS POSSIBLE THAT THE CONNECTION PORT WAS NOT FULLY CONNECTED/TIGHTENED AND/OR THE DEVICE BEING CONNECTED WAS COMPROMISED THUS RESULTING IN THE REPORTED LEAK DIFFICULTIES; HOWEVER THIS CANNOT BE CONFIRMED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED LEAK DIFFICULTIES. BASED ON THE REPORTED INFORMATION AND RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. H11 CORRECTIONS: SUBSEQUENT TO FILING THE FINAL REPORT, IT WAS NOTED THE MFG NARRATIVE WAS INADVERTENTLY LEFT OFF OF THE REPORT. THEREFORE, THE SUPPLEMENTAL MDR IS BEING FILED TO PROVIDE THE MFG NARRATIVE. ADDITIONALLY, THE FOLLOWING STATEMENT INCLUDED IN H11 ON THE PRIOR REPORT STATING, 'THE 7 ADDITIONAL USED DEVICES RECEIVED AND REFERENCED IN B5 WILL BE FILED ON SEPARATE MDR REPORTS', HAS BEEN REMOVED AS THE NOTED DAMAGE TO THE 7 ADDITIONAL USED DEVICES RETURNED WAS REPORTEDLY DUE TO ADDITIONAL TESTS PERFORMED BY THE OPERATING ROOM MEMBERS. THEREFORE, NO REPORTS WILL BE FILED FOR THE 7 ADDITIONAL USED DEVICES.
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. DURING USE, WHILE CONNECTED DIRECTLY TO THE BALLOON, IT WAS IMPOSSIBLE TO INFLATE THE BALLOON AS THE INDEFLATOR COULD NOT HOLD PRESSURE. TWO OTHER INDEFLATORS FROM THE SAME LOT WERE ATTEMPTED WITH THE SAME RESULT. A FOURTH INDEFLATOR FROM THE SAME LOT WAS USED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WAS A DELAY IN THE PROCEDURE BUT THERE WAS NO HARM TO THE PATIENT. SUBSEQUENT TO THE INITIALLY FILED REPORTS, SEVEN ADDITIONAL DEVICES WERE RECEIVED. ONE INDEFLATOR HAD THE FACE PLATE SEPARATED FROM THE HOUSING. ANOTHER HAD THE FACE PLATE SEPARATED AS WELL AS THE NEEDLE SEPARATED AND NOT RETURNED. THE ADDITIONAL RETURNED DEVICES WERE REPORTEDLY USED TO RUN ADDITIONAL TESTS BY THE OPERATING ROOM MEMBERS. NO ADDITIONAL INFORMATION WAS PROVIDED.
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. DURING USE, WHILE CONNECTED DIRECTLY TO THE BALLOON, IT WAS IMPOSSIBLE TO INFLATE THE BALLOON AS THE INDEFLATOR COULD NOT HOLD PRESSURE. TWO OTHER INDEFLATORS FROM THE SAME LOT WERE ATTEMPTED WITH THE SAME RESULT. A FOURTH INDEFLATOR FROM THE SAME LOT WAS USED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WAS A DELAY IN THE PROCEDURE BUT THERE WAS NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 101998 | INDEFLATOR | ACCESSORIES | MAV | ABBOTT VASCULAR INC. | 1000184 | 60418468 | 08717648013591 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | UNSPECIFIED BALLOON |