MAUDE Adverse Event Report: MAQUET CV VASOVIEW 6 PRO; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number C-VH-2400

Device Problem Inflation Problem (1310)

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

Event Date 02/09/2016

Event Type  malfunction  

Manufacturer Narrative

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.A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.Cs-cpl-2016-00154; record id - 106978.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview 6 pro balloon of the btt port after insufflation slowly lost air.A replacement device was used to complete the procedure.The hospital did not report any patient effects.The product is returning.The balloon of the btt port after insufflation slowly lost air after several attempts the btt port was replaced by another one.No harm to the patient occured, no patient "charistics" were recorded.A new kit was opened.

Manufacturer Narrative

(b)(4).The device was returned to the factory for evaluation.The device showed signs of clinical usage and no evidence of blood.No visual defects were observed to the balloon or inflation port.An inflation test was conducted.The balloon was inflated and was observed.After few minutes the size of the balloon started to decrease and the balloon deflated completely.The balloon was inflated again and now submerged in plain water bath to observe the presence of bubbles.At first only the balloon part was submerged in the bath to look for any ruptures.No bubbles were observed.Then the whole btt balloon was submerged in the bath.As soon as the balloon inflation port submerged in the bath, bubbles were observed indicating air leakage through the port.Based on the return condition of the device, the reported complaint was confirmed for the reported failure mode "inflation issue".

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview 6 pro balloon of the btt port after insufflation slowly lost air.A replacement device was used to complete the procedure.The hospital did not report any patient effects.The product is returning.The balloon of the btt port after insufflation slowly lost air after several attempts the btt port was replaced by another one.No harm to the patient occured, no patient characteristics were recorded.A new kit was opened.

• Brand Name: VASOVIEW 6 PRO
• 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: 5488070
• MDR Text Key: 40121382
• Report Number: 2242352-2016-00236
• 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,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2016
• Device Catalogue Number: C-VH-2400
• Device Lot Number: 25118750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2015
• 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