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

Model Number HST III SYSTEM (4.3MM)

Device Problems Premature Activation (1484); Failure to Unfold or Unwrap (1669); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2022

Event Type  malfunction  

Manufacturer Narrative

Trackwise id (b)(6).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 the heartstring iii system 4.3mm was defective- not used.

Event Description

The hospital reported that the heartstring iii system 4.3mm was defective- not used.When the insertion aid was pulled out of the aorta, the little umbrella came out with it.A new device was used to complete the procedure.No harm to the patient.

Manufacturer Narrative

Trackwise id # (b)(4).Corrected section: h-6 from "3190" to "1484".

Manufacturer Narrative

Trackwise # (b)(4).

Event Description

The hospital reported that the heartstring iii system 4.3mm was defective- not used.The seal was loaded correctly.When the insertion aid was pulled out of the aorta, the little umbrella came out with it.The "umbrella" was not stable in the aorta, so it was not possible to make an anastomosis.A new device was used to complete the procedure.No harm to the patient.

Event Description

N/a.

Manufacturer Narrative

Trackwise # (b)(4) updated section: b4, g4, g7, h2, h3, h6, h10, h11 corrected section: h6- corrected to "1669" the device was returned to the factory for evaluation on 10/27/2022.An investigation was conducted on 11/03/2022.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the loading device.The delivery device was returned inside the loading device with the white plunger not depressed and the blue slide lock on which prevents the white plunger from being depressed.The delivery device was removed from the loading device with no physical or visual difficulties observed.The seal and tension spring assembly remained in the loading device.The seal and tension spring assembly was removed from the loading device with no physical or visual difficulties observed.The seal was observed to be partially unraveled on the outer rung of the seal and in a semi taco shape.No other visual defects were observed.Measurements of the delivery device were taken.The inner diameter was measured at 0.195 inches, the outer diameter was measured at 0.218inches ((b)(6)).The length of the delivery tube was measured at 2.50 inches ((b)(6)).The measurement values recorded for the delivery tube were within the tolerance specifications.Based on the returned condition of the device, the reported failure "failure to unfold or unwrap" was confirmed and the analyzed failures "fitting problem" and "unraveled material" were observed.The lot # 3000252562 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.

• 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: 15437749
• MDR Text Key: 305355337
• Report Number: 2242352-2022-00786
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2023
• Device Model Number: HST III SYSTEM (4.3MM)
• Device Catalogue Number: C-HSK-3043
• Device Lot Number: 3000252562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK.; UNK.; UNKNOWN.