MAUDE Adverse Event Report: MAQUET CV VASO VIEW HEMOPRO; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number C-VH-3000

Device Problem Inflation Problem (1310)

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

Event Date 03/10/2016

Event Type  malfunction  

Manufacturer Narrative

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.(b)(4).

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro would not stay inflated.A replacement device was used to complete the procedure.The hospital did not report any patient effects.The product is returning.The btt balloon was not staying inflated.Opened new kit.(b)(4).

Manufacturer Narrative

(b)(4).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 pin hole in the middle of the silicone balloon.The opening was smooth with no removal of material and no tearing.An inflation test was attempted, 25 ml air was introduced into the balloon via syringe.The balloon would not inflate.The product was submerged in a water bath.Bubbles were seen rapidly releasing from the pin hole during the bubble emission test in plain water.The product was viewed under magnification and a pinhole was observed in the center of the balloon, midway between the top and bottom.Based on the condition of the device as found, the reported complaint for "btt would not stay inflated" was confirmed.The device history record (dhr) and manufacturing process was reviewed.The dhr record review shows that the device lot conformed to all specifications and passed a leak test prior to release.Tooling used to assemble the device does not include any object that can cause or contribute to the reported event.No evidence that a manufacturing defect caused or contributed to the reported event could be found during the course of the investigation.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro would not stay inflated.A replacement device was used to complete the procedure.The hospital did not report any patient effects.The product is returning.The btt balloon was not staying inflated.Opened new kit.Please send a replacement to (b)(6).

• Brand Name: VASO VIEW HEMOPRO
• 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: 5548375
• MDR Text Key: 42511031
• Report Number: 2242352-2016-00330
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2016
• Device Catalogue Number: C-VH-3000
• Device Lot Number: 25121509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2016
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2015
• 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: 68 YR