MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HST III SEAL (4.5MM), 5-PACK; CLAMP, VASCULAR

Model Number HST III SEAL (4.5MM), 5-PACK

Device Problem Fitting Problem (2183)

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

Event Date 06/22/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The hospital reported that during a coronary artery bypass procedure the hst iii seal did not load correctly.They used a second device and it worked as intended.There was no harm or adverse event to the patient.

Manufacturer Narrative

Trackwise #: (b)(4).The lot #25163520 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 to the factory for evaluation on 07/05/2022.An investigation was conducted on 08/03/2022.The loading device with the seal still inside was returned along with the delivery device.An additional loading device with no seal or evidence of blood was included with the returned product.A visual inspection was conducted.Signs of clinical use and no evidence of blood were observed.The seal and tension assembly were observed in the body of the loading device, indicating the delivery device was not loaded correctly.The seal and tension spring assembly were removed from the loading device with no physical or visual difficulties.There were no cracks or delamination observed on the seal, which was folded.On the delivery device, the white plunger was depressed and the blue safety lock was off.Measurements of the delivery device were taken; the inner diameter was measured at 0.196 inches, the outer diameter was measured at 0.223 inches (rm2036883).The length of the delivery tube was measured at 2.52 inches (mcv00004217).The measurement values recorded for the delivery tube were within the tolerance specifications.Based on the returned condition of the device, the reported failure "fitting problem" was confirmed.

Event Description

N/a.

• Brand Name: HST III SEAL (4.5MM), 5-PACK
• 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: 15027089
• MDR Text Key: 304612693
• Report Number: 2242352-2022-00614
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607567700307
• UDI-Public: 00607567700307
• Combination Product (y/n): N
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2023
• Device Model Number: HST III SEAL (4.5MM), 5-PACK
• Device Catalogue Number: C-HS-3045
• Device Lot Number: 25163520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1