MAUDE Adverse Event Report: MAQUET CV VASOVIEW 7 XB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number C-VH-3200-J

Device Problems Hole In Material (1293); Inflation Problem (1310)

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

Event Date 07/25/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4) 2015 01:58 pm (gmt-4:00) added by (b)(4): 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, the vasoview 7 xb balloon at the btt port was unable to be inflated, it seemed to have had a hole in it.The hospital did not report any patient effects.The product is returning.

Manufacturer Narrative

(b)(4).The device was returned to the factory for evaluation.It showed signs of clinical usage.A visual inspection was conducted.Peeling of the outer coating was observed.The latex covering had peeled away from the balloon at the top.An inflation test was attempted.The balloon was difficult to inflate and inflated asymmetrically.The area of the balloon where the latex coating had peeled off required less air pressure to inflate.This contributed to the asymmetry.A review of the suture knot location relative to the tear was conducted.The location of the knot was determined to not be related to the tear.Based on the condition of the device as found the reported complaint for "balloon inflated asymmetrically" was confirmed.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, the vasoview 7 xb balloon at the btt port was unable to be inflated, it seemed to have had a hole in it.The hospital did not report any patient effects.The product is returning.

• Brand Name: VASOVIEW 7 XB
• 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: 5105153
• MDR Text Key: 26960661
• Report Number: 2242352-2015-01117
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K041981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2016
• Device Catalogue Number: C-VH-3200-J
• Device Lot Number: 25111012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/24/2015
• 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