MAUDE Adverse Event Report: MAQUET CV ENDOSCOPIC VESSEL HARVESTING; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number C-VH-2400

Device Problems Inflation Problem (1310); Leak/Splash (1354)

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

Event Date 08/05/2015

Event Type  malfunction  

Manufacturer Narrative

September 03, 2015 02:36 pm (gmt-4:00) added by (b)(6): the device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview 6 pro balloon on the btt port wouldn't stay inflated.The procedure was completed with the same device, despite the challenges.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(6).The device was returned to the factory for evaluation.It showed signs of clinical usage and evidence of blood.A visual inspection identified a small puncture near the seam of the silicone balloon, roughly 3mm across.The puncture exhibited smooth sides with no removal of material and no tearing and was not located near the suture knot.The balloon will not inflate.Based on the condition of the device as found the reported complaint was confirmed.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview 6 pro balloon on the btt port wouldn't stay inflated.The procedure was completed with the same device, despite the challenges.The hospital did not report any patient effects.

• Brand Name: ENDOSCOPIC VESSEL HARVESTING
• 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: 5055980
• MDR Text Key: 25671540
• Report Number: 2242352-2015-01043
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K091733
• 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
• Report Date: 08/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2016
• Device Catalogue Number: C-VH-2400
• Device Lot Number: 25112024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2015
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/25/2015
• 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 Age: 71 YR