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

Model Number VH-4000

Device Problem Defective Device (2588)

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

Event Date 08/08/2023

Event Type  malfunction  

Event Description

The hospital reported that during an endoscopic vein harvesting procedure the vasoview hemopro 2 harvester completed the dissection part and about to start the branch management part the harvester noticed that the cannula c- ring diameter was small not able to engage the branch.They complete the procedure with the new one.No procedural delay.No harm to the patient.

Manufacturer Narrative

Trackwise id (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.

Manufacturer Narrative

Trackwise # (b)(4).The device was returned to the factory for evaluation on (b)(6) 2023.A photograph was provided by the account.A photographic inspection was conducted.Two c-rings are visible, the rightmost c-ring with a normal inner diameter and the leftmost c-ring with an undersized inner diameter.Only the tops of the c-rings are visible in the photo.An investigation was conducted on (b)(6) 2023.A visual inspection was conducted.Signs of clinical use and no evidence of blood were observed on the device.The cannula handle was returned separated into two halves.The halves were able to be snapped together with no physical difficulties.The distance between the edges of the c-ring was measured to be approximately 0.0997".Per rm2047671 rev.K aql l, the measurement should be 0.165" ±0.005".The measurement is out of specification.Based on the returned condition of the device, and investigation results, the reported failure "defective device; undersized c-ring" was confirmed.The lot # 3000294361 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.

• 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: 17683423
• MDR Text Key: 322640015
• Report Number: 2242352-2023-00733
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700406
• UDI-Public: 00607567700406
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• 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: 3000294361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK.; UNKNOWN.
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 64 KG