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

Model Number HST III SYSTEM (3.8MM)

Device Problems Component Missing (2306); Detachment of Device or Device Component (2907)

Patient Problem Laceration(s) (1946)

Event Date 04/20/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.

Event Description

The hospital reported that during a coronary artery bypass procedure using hst iii system (3.8mm).After shooting the delivery system to patient's aorta and removing the seal, (there's no tension or resistance felt, just as usual) they found that the seal was only partially out of the aorta.Part of the seal is still in patient's body.They tried to locate the rest taking to ct but was unable to find it.There was uncertain shadow shown in the ct so patient received angiography the next day.They were able to locate it in the right iliac artery but couldn't remove it.There's no severe adverse event till now, but she's in the icu being monitored.Patient is under crrt in the icu.

Manufacturer Narrative

Trackwise id (b)(4).Updated section: b-4, d-10, g-4, g-7, h-2, h-10, h-11.Corrected section: h-3 device not eval provide code: from "other" to "device evaluation anticipated, but not yet begun.".

Event Description

N/a.

Manufacturer Narrative

(b)(4).Corrected sections: h6 - changed problem code to only 2907.The device was returned to the factory for evaluation on 05/16/2022.Photographs were provided by the account.A photographic inspection was conducted.Signs of clinical use and evidence of blood was observed.There were two anchor's observed in the photograph.One anchor was observed attached to a completely unraveled seal that had blood on it.The other anchor was observed to be detached from a seal.There were no tension spring assemblies observed in the photograph.A visual inspection was conducted.The delivery device was returned inside the loading device with the white plunger fully depressed and the blue safety lock off which allows for the white plunger to be depressed.The anchor of the seal was returned outside the device.The delivery device was removed from the loading device with no physical or visual difficulties.Signs of clinical use and evidence of blood was observed on the delivery device which indicates an attempt was made to introduce the device into the aorta.No measurements of the delivery device were taken due to the presence of blood.Only the anchor was returned for evaluation.The anchor was observed to be intact, no visual defects were observed.The end of the string was observed to be cut.Blood was observed on the tail of the anchor.Based on the photographic inspection as well as the investigation results, the reported failure "missing component/detachment of device or device component" was confirmed, however we are unable to determine when the failure occurred.The lot # 25160840 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.

Event Description

N/a.

• Brand Name: HST III SYSTEM (3.8MM)
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 14349326
• MDR Text Key: 291326370
• Report Number: 2242352-2022-00407
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607567700314
• UDI-Public: 00607567700314
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K130382
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2022
• Device Model Number: HST III SYSTEM (3.8MM)
• Device Catalogue Number: HSK-3038
• Device Lot Number: 25160840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female