MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HST III SYSTEM (4.3MM); CLAMP, VASCULAR

Model Number HST III SYSTEM (4.3MM)

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/22/2022

Event Type  Injury  

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 (4.3mm).After the aortotomy with the aortic cutter and insertion of the hsk seal, the surgeon wanted to adjust the hsk to the aorta because the bleeding was still ongoing.When aligning the device, the holding thread with the tension spring came loose from the device.It could no longer be used like this.There was profuse bleeding from the aortotomy hole.About 500-600 ml was lost.No blood transfusion, a cell saver was used.The surgeon did not want to use another hsk.The aorta could no longer be clamped tangentially, but the aorta had to be completely clamped again and the heart plegged.The bypass anatomoses on the aorta were performed with ischemia.Heartstring could no longer be used.First suction and later the aorta was clamped again since tangential clamping was not possible, then the heart was cardio plegged and the aortic anastomoses from the bypass was performed under ischemia to stop the bleeding.There was a procedural delay because the intervention had to be carried out.The hospital did not report any patient effects.

Manufacturer Narrative

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

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

Trackwise # (b)(4).Analysis of production: (3331/213/67) the device history records review concluded that 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 manufacturing process and the reported failure.Historical data analysis: (4109/213/67) the review of the historical data indicates that no other similar complaints was reported for the same lot number and reported failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period mar-2020 through feb-2022 was reviewed.There were no triggers identified for the review period.Communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.Testing of actual/suspected device: (10/13/61) the device was returned to the factory for evaluation on 03/24/2022.An investigation was conducted on 04/05/2022.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the unraveled seal which indicates an attempt was made to introduce the device into the aorta.The unraveled seal was observed to be detached from the tension spring assembly that had the blue thread intact.The delivery device was returned outside the loading device with the white plunger fully depressed and the blue safety off, which allows for the white plunger to be depressed.No measurements of the delivery device were taken due to the presence of blood which indicates an attempt was made to introduce the device into the aorta.There were no visual defects observed on the loading device.No other visual defects were observed.Based on the returned condition of the device, the reported failure "detachment of device or device component" was confirmed.

• Brand Name: HST III SYSTEM (4.3MM)
• 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: 13825335
• MDR Text Key: 290290602
• Report Number: 2242352-2022-00241
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607567700321
• UDI-Public: 00607567700321
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K130382
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2022
• Device Model Number: HST III SYSTEM (4.3MM)
• Device Catalogue Number: HSK-3043
• Device Lot Number: 25161506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 98 KG