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

Model Number HST III SYSTEM (3.8MM)

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

Trackwise id# (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 a coronary artery bypass procedure using hst iii system (3.8mm).The cutter was pressed when the aorta cutter cover was removed to use this product (safety lock is also released).It was used as a new product and the surgery was finished, and there is no damage to patient.

Manufacturer Narrative

Corrected section: h-3 device not eval provide code: from "other" to "device evaluation anticipated, but not yet begun." trackwise id # (b)(4).

Event Description

The hospital reported that during a coronary artery bypass procedure using hst iii system (3.8mm).The cutter was pressed when the aorta cutter cover was removed to use this product (safety lock is also released).It was used as a new product and the surgery was finished, and there is no damage to patient.

Manufacturer Narrative

Trackwise # (b)(4).The lot # 25153605 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.The device was returned with the loading, delivery and tension spring and seal to the factory for evaluation on 05jan2021.A photograph was provided by the account.The aortic cutter could be seen without a cap.The aortic cutter was observed to be deployed.Delivery device can be observed inside loading device.The tension spring and seal can be observed inside the loading device.An investigation was conducted on 22apr2021.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed on the body of the aortic cutter.The safety lock was disengaged with the cutter and spiral needle deployed.The cutter was in a deployed state with the actuation button approximately 1 inch inside the tool.The tip of the needle was observed to be bent.The blade was in a deployed state and we were unable to determine the amount of force for the deployment of the needle.Measurements were taken of the cutter; from the tip of the needle to the grey part is.599, from the button that is pressed in is.403" inside the cutter, which is within normal limits.Delivery device was returned inside loading device.The delivery device was removed from the loading device.The tension spring and seal remained inside the loading device.The white plunger on the delivery device remained not pressed in and the blue lock remained in the unlocked position.The seal was taken out from the loading device for inspection.There was no sign of crack/delamination on the seal.Dimensions of the delivery tube were taken.The inner diameter was measured at 0.199 inches, the outer diameter was measured at 0.220 inches.The length of the delivery tube was measured at 2.500 inches.The measurement values recorded for the delivery tube were within the tolerance specifications.There were no other visual defects observed.Based on the returned condition of the device, the reported failure "mechanical issue" was not confirmed but the analyzed failures "material twisted/ bent needle" and ¿fitting problem" were confirmed.The dhr, shop floor paperwork was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.The dhr, shop floor paperwork is available for review as an attachment to the record.

Event Description

The hospital reported that during a coronary artery bypass procedure using hst iii system (3.8mm).The cutter was pressed when the aorta cutter cover was removed to use this product (safety lock is also released).It was used as a new product and the surgery was finished, and there is no damage to patient.

• Brand Name: HST 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: 11111069
• MDR Text Key: 225094054
• Report Number: 2242352-2021-00029
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2021
• Device Model Number: HST III SYSTEM (3.8MM)
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25153605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 01/04/2021
• Supplement Dates Manufacturer Received: 01/05/2021; 04/26/2021
• Supplement Dates FDA Received: 01/28/2021; 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 64