MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HSK III SYSTEM (3.8MM); CLAMP, VASCULAR

Model Number HST III SYSTEM (3.8MM)

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

Trackwise id # (b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.

Event Description

The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm) aortic cutter misfired.New product opened and functioned without issue.The hospital did not report any patient effects.

Event Description

The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm) aortic cutter misfired.New product opened and functioned without issue.The hospital did not report any patient effects.

Manufacturer Narrative

Trackwise #: (b)(4).The lot # 25154920 history record review was completed.There was one ncmrs , rework, or deviations documented for the reported lot number.[ncmr #17209-supplier (b)(4) notified maquet that during the final inspection of (b)(4) batch number 7441993-108285, particulates were found in the casing of the 3.8mm, which were attributed to nonconforming springs.(b)(4) added that the nonconforming springs came from century spring batch #68011.There were additional lots that were built with this century spring batch #68011 which was shipped to maquet.These batches were (b)(4) batches # 7397157-107796, #7441991-108053, #7441992-108134, #7442510-108003eng1, 7442511-108013eng2, 7442512-108022eng3 for the cv000001733 (3.8mm aortic cutter), and one vendor batch #7397158-107933 of cv000001734 (4.3mm aortic cutter).These batches are being placed in quarantine due to this notification.] based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.The device was returned to the factory for evaluation on 12/29/2020.An investigation was conducted on 01/19/2021.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the aortic cutter blade, indicating that an attempt was made to introduce the device into the aorta.The cutter and the needle were extended past the aortic stop and were visible.The needle was observed to be fully deployed and slightly bent.The actuation button was fully depressed, and the lock button was dis-engaged.Based on the returned condition of the device, the reported failure "premature deployment" was not confirmed, but was confirmed for the analyzed failure "material twisted/ bent needle".

• Brand Name: HSK III SYSTEM (3.8MM)
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 11127179
• MDR Text Key: 225598334
• Report Number: 2242352-2021-00039
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607567700314
• UDI-Public: 00607567700314
• Combination Product (y/n): N
• PMA/PMN Number: K130382
• 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: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2021
• Device Model Number: HST III SYSTEM (3.8MM)
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25154920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 105