MAUDE Adverse Event Report: MAQUET CV VASOVIEW HEMOPRO 2; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number C-VH-4000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 harvester stated that the distal insufflation on the harvesting cannula would not "blow" co2.Harvester aborted evh and opened the leg.The patient is fine and outcome wasn't altered due to the device.

Manufacturer Narrative

Internal complaint number: (b)(4).Autonumber: (b)(4).Device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed on the cannula handle, the distal blunt tip and the c-ring.The distal insufflation connector appeared intact.The device was evaluated for the proper air flow through the distal insufflation tube using a calibrated "uson".A reference endoscope and a reference harvesting tool were inserted into the reported cannula and an air supply tubing was connected to the distal insufflation connector luer fitting.An air flow test was then conducted.The device passed the air flow test.Based on the returned condition of the device and the evaluation results, the reported failure mode "improper flow or infusion" was not confirmed.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 harvester stated that the distal insufflation on the harvesting cannula would not "blow" co2.Harvester aborted evh and opened the leg.The patient is fine and outcome wasn't altered due to the device.

Manufacturer Narrative

Internal complaint number: (b)(4).Autonumber: (b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 harvester stated that the distal insufflation on the harvesting cannula would not "blow" co2.Harvester aborted evh and opened the leg.The patient is fine and outcome wasn't altered due to the device.

• Brand Name: VASOVIEW HEMOPRO 2
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 7488716
• MDR Text Key: 107439521
• Report Number: 2242352-2018-00424
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2020
• Device Catalogue Number: C-VH-4000
• Device Lot Number: 25137155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2018
• Initial Date FDA Received: 05/04/2018
• Supplement Dates Manufacturer Received: 05/14/2018; 06/20/2018
• Supplement Dates FDA Received: 06/13/2018; 06/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other