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

Model Number VH-4000

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2024

Event Type  Injury  

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 c ring component broke in the tunnel.Per photos provided by the complainant, the c-ring has completely detached from the device.They noticed that the c ring was slightly protruding from the end of the cannula even when the blue c ring slider was completely pulled back.(about 1mm) they elected to use it anyway.When they attempted to push out the c ring to isolate a branch, they saw that it came out funny as if the two wires holding the c ring were detached from the usual parallel configuration.They pulled out completely from the tunnel and then saw that one limb of the c ring was disconnected from the cannula.They cut the second limb of the c ring.They kept the same hp2 to finish sealing and cutting the remaining branches who didn't require c ring.Additional incisions requires to ligate a very large branch they thought they would've needed the c ring to isolate.They didn't have to create an incision to retrieve the c ring.They removed it and used a second c-vh-4000.Apart from this opening to seal and ligate the large branch, no delays were encountered.No bleeding following the procedure and a very good quality of vein.The patient wasn't injured.

Event Description

N/a.

Manufacturer Narrative

Trackwise (b)(4).Updated sections: b4, d9, g3, g6, h2, h3, h6, h10, h11 corrected sections: h2--type of reportable event corrected from "malfunction" to "serious injury" the device was returned to the factory for evaluation on 03/12/2024.Photographs were provided by the account.A photographic inspection was conducted.The heater wire and clear silicone insulation were observed to be intact from what is visible in the photograph.The scope wash tubing and half of the c-ring were observed separate to the cannula.The other half of the c-ring is not visible.An investigation was conducted on 03/14/2024.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed.The heater wire was observed to be detached from the tip of the hot jaw and bent downwards.The clear silicone insulation of both the hot and cold jaws was observed to be peeled completely off the jaws and was not returned for evaluation.The c-ring was observed to be cut in half down the center with signs of melting near the flanking curved areas.The other half of the c-ring and scope wash tubing were not attached to the cannula and were not returned.Based on the photographic inspection, returned condition of the device, and the evaluation results, the reported failure "break; c-ring", as well as the analyzed failures "material twisted/bent; wire" and "peeled; jaw" was confirmed.Specific actions for the reported failure, break; c-ring, are being maintained and documented under maquet's corrective and preventive action (capa) system.The lot # 3000353044 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: 18873401
• MDR Text Key: 337445372
• Report Number: 2242352-2024-00225
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700406
• UDI-Public: 00607567700406
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VH-4000
• Device Catalogue Number: VH-4000
• Device Lot Number: 3000353044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention