MAUDE Adverse Event Report: MAQUET CV VASOVIEW HEMOPRO 2; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number C-VH-4000

Device Problems Intermittent Continuity (1121); Inflation Problem (1310); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.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 Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 was working intermittently and the balloon was not inflating.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 was working intermittently and the balloon was not inflating.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Internal complaint # (b)(4).Autonumber # (b)(4).The device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use and slight evidence of blood was observed.Blood and tissue particles were observed on the heater wire.The silicon insulation was observed to be intact.A pre-cautery test was performed per the instruction for use (ifu) with a reference cable, adapter and reference power at level 3.0.During the pre-cautery test, it produced steam and audible beeping sound during five (5) 3-second activations.To evaluate the safety shut down system, a poly-fuse activation test was performed 5 times over 10 minutes.The device shut off after the period of sustained activation and reactivated after a 10-second cooling period with no incident each time.The jaws were cleaned gently with saline and gauze pad as indicated in the instructions for use.A temperature and resistance evaluation was conducted to evaluate the device function.The resistance value was measured at 0.688 ohms which is within hemopro 2 final test specification.The device passed the temperature measurement test.The displayed temperature increased and turned ¿green¿ within the 2 second specified timeframe.The displayed temperature decreased once the toggle switch was released.A microscopic inspection was conducted.The heater wire was observed to be slightly flexed away from the center of the hot jaw, but remained attached at the base and tip of the hot jaw.No other visual defects were observed.The btt was not returned for evaluation.Thus no investigation could be performed.Based on the returned condition of the device and the results of the investigation, reported failure "intermittent continuity" was not confirmed and due to the non-return of the btt, the reported failure ¿inflation issue", was not confirmed, but was confirmed for the analyzed failure "material twisted/bent" was confirmed.Specific actions for the analyzed failure mode are being maintained and documented under maquet¿s failure investigation report (fir) system.

• Brand Name: VASOVIEW HEMOPRO 2
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8411532
• MDR Text Key: 138660365
• Report Number: 2242352-2019-00283
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K101274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2021
• Device Catalogue Number: C-VH-4000
• Device Lot Number: 25143854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Device Age: YR
• Date Manufacturer Received: 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 128