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

Model Number	VV 6 ACCESSORY PACK
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Corrected section: h-3 device not eval provide code: from "other" to "device evaluation anticipated, but not yet begun." (b)(4).
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 11378340
• Report Number: 2242352-2021-00175
• Device Sequence Number: 3782049
• Product Code: GEI
• UDI-Device Identifier: 00607567700376
• UDI-Public: 00607567700376
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K041981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2021

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 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
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 03/01/2021; 04/16/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 03/22/2021; 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR