MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW 7 XB BISECTOR (OUS); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VASOVIEW 7 XB BISECTOR (OUS)
Medical Device Problem Codes	Improper Flow or Infusion (2954); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Respiratory Acidosis (2482); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, vasoview 7 xb bisector, the vein got damaged and through this opening co2 might have entered into the venous system resulted in increased etco2 level.Ten minutes after the evh incision, the end tidal co2 (etco2) began to rise progressively and peaked at 88 mmol/l.Immediate response included checking the ventilation and suctioning the patient.An arterial blood gas (abg) demonstrated severe respiratory acidosis without impairment of oxygenation (ph 7.13; paco2 87.9; pao2 201 (fio21); single breath counting (sbc) 29.2 mmol/l).Immediately after the cessation of co2 insufflation, there was a remarkable improvement in the etco2 the temperature of the patient remained normal.Transesophageal echocardiogram (tee) depicted no evidence of air in the right atrium (ra) or in the inferior vena cava.Similarly, there was no evidence of rebreathing or hypermetabolic state such as malignant hyperthermia.A repeat arterial blood gas after 30 minutes exhibited a similar picture.Hand ventilation did not result in any significant change in the paco2 levels.The heart rate increased by 12 beats/min.Body temperature, heart rhythm, and blood pressure remained unchanged.They immediately asked the harvester to abandon the evh and convert into traditional open technique to harvest the vein and they completed the cabg procedure without further complications.
Additional Manufacturer Narrative
Trackwise id (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
(b)(4).Corrected sections: h6 problem code updated sections: b4, g4, g7, h2, h10, h11.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Trackwise # (b)(4).A lot history record review was completed for the last two lots 25151537 and 25156741 the last 2 lots shipped to the account prior to the event/aware date.For the lot # 25151537- 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.Sc (b)(6) 2023 for the lot # 25156741.There were no ncmrs, rework, or deviations documented for the last 3 lots shipped to the account.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.

• Brand Name: VASOVIEW 7 XB BISECTOR (OUS)
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 15621453
• Report Number: 2242352-2022-00864
• Device Sequence Number: 6345322
• Product Code: GEI
• UDI-Device Identifier: 00607567700437
• UDI-Public: 00607567700437
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K041981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Literature,Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VASOVIEW 7 XB BISECTOR (OUS)
• Device Catalogue Number: VH-3200-W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2022
• Supplement Date Received by Manufacturer: 05/17/2023; 06/29/2023
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 06/08/2023; 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male