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

Model Number VH-4000

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4) 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 btt port balloon failed to maintain desired inflation size.Per video provided by the complainant, the balloon did not inflate and there was evidence of blood.Upon inspection, a leakage was found at the rim of the balloon, leading to its inability to maintain the desired inflation size.They proceeded with the procedure due to adequate tunnel visualization.No delay.The patient was unharmed and is in stable condition.

Manufacturer Narrative

Trackwise#: (b)(4).Updated sections: b4, d9, g3, g6, h2, h3, h6, h10.The device was returned to the factory for evaluation on 03/15/2024.A photograph and video was provided by the account.A photographic evaluation was conducted.Signs of clinical use and evidence of blood was observed.A video inspection was conducted.Signs of clinical use and evidence of blood was observed.A syringe with fluid was used to inflate the btt.The btt did not inflate and a small stream of liquid was observed coming out of the btt.No other visual defects were observed.An investigation was conducted on 03/19/2024.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed.A mechanical investigation was conducted.A 5cc syringe, filled with saline was attached to the co2 line on the btt and squeezed the syringe to spray the saline.There was no backflow observed in the co2 line.A leak was observed on the side of the silicone balloon.The btt was unable to be inflated.No visual defects were observed on the silicone btt.Based on the condition of the device, the reported failure "inflation issue" was confirmed.Specific actions for the reported failure mode is being maintained and documented under maquet's corrective and preventive action (capa) system.The lot # 3000345542 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.

Event Description

N/a.

• Brand Name: VASOVIEW HEMOPRO 2
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 18913405
• MDR Text Key: 337773352
• Report Number: 2242352-2024-00250
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700406
• UDI-Public: 00607567700406
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K101274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VH-4000
• Device Catalogue Number: VH-4000
• Device Lot Number: 3000345542
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2024
• Date Device Manufactured: 10/04/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 74 KG