VASOVIEW HEMOPRO
Report
- Report Number
- 2242352-2023-00280
- Event Type
- Malfunction
- Date Received
- April 5, 2023
- Date of Event
- March 17, 2023
- Report Date
- May 26, 2023
- Manufacturer
- MAQUET CARDIOVASCULAR LLC
- Product Code
- GEI
- UDI-DI
- 00607567701250
- PMA / PMN Number
- K153194
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
TRACKWISE # (B)(4). CORRECTED SECTION: H4- IF OTHER PROVIDE CODE -EXPLAIN- DEVICE RETURNED, H6 -INVESTIGATION FINDINGS (1) CORRECTED CODE "3221" TO "13" - DEVICE RETURNED, H6 -TYPE OF INVESTIGATION REMOVED CODE " 4114- DEVICE RETURNED, D10- DEVICE AVAILABLE FOR EVAL- DEVICE RETURNED. THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 05/11/2023. AN INVESTIGATION WAS CONDUCTED ON (B)(6) 2023. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED. CHARRED MATERIAL WAS OBSERVED ON THE HEATER WIRE. THE HEATER WIRE WAS OBSERVED TO BE SLIGHTLY FLEXED AWAY FROM THE HOT JAW CLOSEST TO THE BASE OF THE HOT JAW DUE TO NORMAL CLINICAL USE. THE GRAY SILICONE INSULATION ON THE TIP OF THE COLD JAW WAS OBSERVED TO BE PEELED BACK EXPOSING THE COLD METAL TIP. THE GRAY SILICONE INSULATION ON THE HOT JAW WAS OBSERVED TO BE INTACT WITH NO VISUAL DEFECTS OBSERVED. THE CANNULA WAS ALSO RETURNED FOR EVALUATION. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED. THE C-RING WAS OBSERVED TO BE CUT IN HALF DOWN THE CENTER WITH SIGNS OF MELTING NEAR THE FLANKING CURVED AREAS. THE SCOPE WASH TUBING AND RETENTION RIB REMAINED ATTACHED TO THE CANNULA DUE THE PRESENCE OF A RETENTION RIB. THERE WERE NO OTHER VISUAL DEFECTS OBSERVED. BASED ON THE RETURNED CONDITION OF THE DEVICES AS WELL AS THE EVALUATION RESULTS, THE REPORTED FAILURE "MATERIAL TWISTED/ BENT WIRE" WAS NOT CONFIRMED, HOWEVER THE ANALYZED FAILURES "PEELED; DELAMINATED; JAW" AND "BREAK; C-RING" WERE OBSERVED. SPECIFIC ACTIONS FOR THE FAILURE MODES ARE BEING MAINTAINED AND DOCUMENTED UNDER MAQUET'S CORRECTIVE AND PREVENTIVE ACTION (CAPA) SYSTEM.
TRACKWISE ID 790734. THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.
(B)(4). THE LOT # 3000293522 HISTORY RECORD REVIEW WAS COMPLETED. THERE WERE NCMRS , REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED LOT NUMBER. BASED ON THE DHR/LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE BATCH MANUFACTURING PROCESS AND THE REPORTED FAILURE.
TRACKWISE#: (B)(4).
N/A.
THE HOSPITAL REPORTED THAT AT THE BEGINNING THE ENDOSCOPIC VEIN HARVESTING PROCEDURE THE VASOVIEW HEMPORO VH-3500 JAWS BROKE. A NEW KIT WAS USED TO DO THE CASE. NO PATIENT EFFECTS REPORTED.
N/A.
THE HOSPITAL REPORTED THAT AT THE BEGINNING OF THE ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW HEMPORO VH-3500 JAWS BROKE. THE JAWS OF THE HARVESTING TOOL WERE NOT OPEN (EVEN SLIGHTLY) DURING INSERTION. NO RESISTANCE WAS REPORTED. NO COMPONENT FELL IN THE PATIENT. A NEW KIT WAS USED TO DO THE CASE. NO PROCEDURAL DELAY. NO PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2254798 | VASOVIEW HEMOPRO | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | MAQUET CARDIOVASCULAR LLC | VH-3500 | 3000293522 | 00607567701250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Prefer Not To Disclose |