MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HST; CUTTER, SURGICAL

Model Number AORTIC CUTTERS, 5-PACK (3.8MM)

Device Problems Packaging Problem (3007); Inaccurate Information (4051)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.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 preparation for a coronary artery bypass procedure, hsiii aortic cutter tr.Unit 3.8mm size notation printed on the main body is different on the front and back, the front was 3.8mm and the back was 4.3mm.Same device was used for operation.The hospital did not report any patient effects.

Manufacturer Narrative

Updated sections: d10,g4,g7,h2,h3,h6,h10.H6 correction: device codes changed to "packaging issue." internal complaint number: (b)(4).The device was returned to the factory on 09/23/2019.An investigation was conducted on 03/20/2020.A review of the video received from the client was performed.The video shows the aortic cutter with the reported labeling of size issue.An engineering evaluation was conducted to inspect the appropriate size of the device.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.One side of the aortic cutter stated 3.8mm while the other side stated 4.3mm.There were no other visual defects observed.The cutter was received in a deployed state.Based on the returned condition of the device, the reported failure "packaging issue" was confirmed.The defect was communicated to the supplier and a scar has been issued.

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure, hsiii aortic cutter tr.Unit 3.8mm size notation printed on the main body is different on the front and back, the front was 3.8mm and the back was 4.3mm.Same device was used for operation.The hospital did not report any patient effects.

• Brand Name: HST
• Type of Device: CUTTER, SURGICAL
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8959550
• MDR Text Key: 156479144
• Report Number: 2242352-2019-01004
• Device Sequence Number: 1
• Product Code: FZT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2020
• Device Model Number: AORTIC CUTTERS, 5-PACK (3.8MM)
• Device Catalogue Number: AC-3038
• Device Lot Number: 25146500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1