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

Model Number VASOVIEW HEMOPRO 2

Device Problem Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Date 01/07/2021

Event Type  malfunction  

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 preparation for an endoscopic vein harvesting procedure, vasoview hemopro 2 clamping jaw extraction device is defective.When removing it from the packaging, it was noticed that the clamping jaw/branch was loosening on the removal instrument.The hemopro 2 device could not be inserted like this and a new hemopro 2 device was opened and then inserted.No patient involvement.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, vasoview hemopro 2 clamping jaw extraction device is defective.When removing it from the packaging, it was noticed that the clamping jaw / branch was loosening on the removal instrument.The hemopro 2 device could not be inserted like this and a new hemopro 2 device was opened and then inserted.No patient involvement.

Manufacturer Narrative

(b)(4).The lot # 25153820 history record review was completed.There were no 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.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, vasoview hemopro 2 clamping jaw extraction device is defective.When removing it from the packaging, it was noticed that the clamping jaw / branch was loosening on the removal instrument.The hemopro 2 device could not be inserted like this and a new hemopro 2 device was opened and then inserted.No patient involvement.

Manufacturer Narrative

Trackwise # (b)(4) corrected sections: h3, h6, h3 ¿device evaluated by mfg?¿ from ¿no¿ to ¿yes¿, h3 -device not evaluated corrected from ¿other¿ to blank, h3- if other provide code explain corrected from ¿device not returned¿ to blank , h-6: type of investigation corrected from ¿device not returned¿ to ¿testing of actual/suspected device¿, h-6: investigation findings: corrected from ¿no findings available¿ to ¿operational problem identified¿, h-6 investigation conclusion: corrected from ¿no problem detected¿ to ¿known inherent risk of device.¿ the device was returned to the factory on 04/20/202.While it was reported that there was no patient involvement, signs of clinical use and evidence of blood was observed on the harvesting handle.The heater wire was observed to be flexed away from the hot jaw at the center of the hot jaw, with detachment at the tip of the hot jaw.The clear silicone insulation on both the cold and hot jaws was observed to be intact.No visual defects were observed.No electrical testing was conducted due to the extend of the damage to the heater wire.Based on the returned condition of the device, the reported failure "material twisted/ bent wire" was confirmed.

• Brand Name: VASOVIEW HEMOPRO 2
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 11332970
• MDR Text Key: 232000142
• Report Number: 2242352-2021-00130
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700406
• UDI-Public: 00607567700406
• Combination Product (y/n): N
• PMA/PMN Number: K101274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2022
• Device Model Number: VASOVIEW HEMOPRO 2
• Device Catalogue Number: VH-4000
• Device Lot Number: 25153820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1