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

Model Number HST III SYSTEM (4.3MM)

Device Problem Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/11/2022

Event Type  malfunction  

Manufacturer Narrative

Trackwise id (b)(4).

Event Description

Related to 617978.The hospital reported that the hst iii system (4.3mm) could not be triggered.

Manufacturer Narrative

Trackwise#: (b)(4).The device was returned to the factory for evaluation on 06/20/2022.An investigation was conducted on 08/03/2022.A visual inspection was conducted.Signs of clinical use and evidence of blood were found on the loading device, delivery device, seal, and tension mechanism.The delivery device was returned outside the loading device with the blue safety lock off, which allowed the white plunger to be depressed.Blood was visible inside the delivery tube.The seal and tension mechanism were returned outside the delivery device with no cracks or delamination observed on the seal.Measurements of the delivery device were taken; the inner diameter was measured at 0.196 inches, the outer diameter was measured at 0.222 inches ((b)(6)).The length of the delivery tube was measured at 2.528 inches ((b)(6)).The measurement values recorded for the delivery tube were within the tolerance specifications.Based on the returned condition of the device and no specific failure reported, the complaint is not confirmed.The lot # 25161506 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: 14316353
• MDR Text Key: 294778735
• Report Number: 2242352-2022-00376
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: No
• 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: C-HSK-3043
• Device Lot Number: 25161506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2022
• 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