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

Catalog Number C-VH-4000

Device Problems Break (1069); Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590)

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

Event Date 03/19/2018

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 while doing harvest yesterday, this happened inside the leg and looked like a piece came off.They irrigated and irrigated and hopefully nothing was left inside.They went back in and grabbed a suspicious thing that looked like a burned tiny piece plastic.A replacement device was used to complete the procedure.

Manufacturer Narrative

(b)(4).A lot history record review was completed for lots 25135858, 25135879, 25136452 and 25136380 the last 4 lots shipped to the account prior to the event date.There were no ncmr¿s for the reported lot number.The device was not returned to maquet cardiac surgery for investigation, however based on the photographs provided, signs of clinical use and evidence of blood and charred tissue were observed on the heater wire.The silicon insulation was observed to be intact.The heater wire was observed to be detached from the tip of the jaw, and remained attached to the base of the jaw.Based on the photographs provided, the reported failure "peeled jaw" was not confirmed, however it was confirmed for the analyzed failure "bent wire".Specific actions for the analyzed failure mode are being maintained and documented under maquet¿s failure investigation report (fir) system.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 while doing harvest yesterday, this happened inside the leg and looked like a piece came off.They irrigated and irrigated and hopefully nothing was left inside.They went back in and grabbed a suspicious thing that looked like a burned tiny piece plastic.A replacement device was used to complete the procedure.

• Brand Name: VASOVIEW HEMOPRO 2
• 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: 7422693
• MDR Text Key: 105200912
• Report Number: 2242352-2018-00322
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-VH-4000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 05/24/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 133