MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VV 6 ACCESSORY PACK; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VV 6 ACCESSORY PACK

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2021

Event Type  Injury  

Manufacturer Narrative

Trackwise id # (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 using port from vv 6 accessory pack.Insufflation was not working.They swapped the port out and still could not get it to work.This is the second port that they could not get co2 insufflation to flow through the port.The hospital did not report any patient effects.

Manufacturer Narrative

Corrected section: h-3 device not eval provide code: from "other" to "device evaluation anticipated, but not yet begun." (b)(4).

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using port from vv 6 accessory pack.Insufflation was not working.They swapped the port out and still could not get it to work.This is the second port that they could not get co2 insufflation to flow through the port.The hospital did not report any patient effects.

Manufacturer Narrative

Internal complaint number: (b)(4).The lot # 25149415 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.The device was returned to the factory for evaluation on 03/01/2021.An investigation was conducted on 03/29/2021.Signs of clinical use and evidence of blood was observed on the btt.No visual defects were observed.A mechanical evaluation was conducted.The btt was able to be inflated.No visual defects were observed on the silicone btt.A 5cc syringe, filled with saline was attached to the co2 line on the btt and squeezed the syringe to spray the saline.There was no backflow observed in the co2 line.Based on the condition of the device, the reported failure "no flow" was not confirmed.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using port from vv 6 accessory pack.Insufflation was not working.They swapped the port out and still could not get it to work.This is the second port that they could not get co2 insufflation to flow through the port.The hospital did not report any patient effects.

• Brand Name: VV 6 ACCESSORY PACK
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 11378340
• MDR Text Key: 233486412
• Report Number: 2242352-2021-00175
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700376
• UDI-Public: 00607567700376
• Combination Product (y/n): N
• PMA/PMN Number: K041981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2021
• Device Model Number: VV 6 ACCESSORY PACK
• Device Catalogue Number: C-VH-2004
• Device Lot Number: 25149415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR