MAUDE Adverse Event Report: MAQUET CV HEMOPRO2 EXTENSION CABLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number C-VH-4030

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Patient Involvement (2645)

Event Date 12/21/2018

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 post use of an endoscopic vein harvesting procedure, hemopro2 extension cable connector was sticking when attempting to disconnect.No patient involvement.

Manufacturer Narrative

Internal complaint number: (b)(4).Autonumber : # (b)(4).The hemopro2 extension cable device was returned to the factory for evaluation.Signs of clinical use and no evidence of blood were observed.A visual inspection was conducted.No defects were observed.The device was evaluated for connector function with reference hemopro 2 per instructions for use (ifu).The arrows were lined up on the hemopro 2 and the extension cable; the device connected without incident.The device was disconnected by pulling back on the extension cable at the connector collar; the device disconnected without difficulty.Both connection ends were evaluated 5 times.We were unable to reproduce the reported failure.Based on the returned condition of the device and the results of the investigation the reported failure mode ¿connection; cord; difficult to detach from device/adaptor¿ was not confirmed.

Event Description

The hospital reported that post use of an endoscopic vein harvesting procedure, hemopro2 extension cable connector was sticking when attempting to disconnect.No patient involvement.

• Brand Name: HEMOPRO2 EXTENSION CABLE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8259107
• MDR Text Key: 133483936
• Report Number: 2242352-2019-00074
• 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: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-VH-4030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Date Manufacturer Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1