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

Model Number HST III SYSTEM (3.8MM)

Device Problems Mechanical Problem (1384); Premature Activation (1484); Misfire (2532)

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

Event Date 04/29/2022

Event Type  malfunction  

Manufacturer Narrative

(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, hst iii system (3.8mm), the aortic cutter is pushed as soon as the safety lock of the heartstring cutter is activated.Attempt made to achieve adequate hemostasis was successful.After that, only aorta cutter used new h/s to finish the operation.There is no unusual event for the patient.

Manufacturer Narrative

Trackwise id # (b)(4).Corrected section: h6 problem code changed.

Manufacturer Narrative

Trackwise#: (b)(4).The device was returned to the factory for evaluation on 05/16/2022.A photograph evaluation was conducted.Signs of clinical use and no evidence of blood was observed.The aortic cutter was observed to be intact, with no visual defects observed.A visual inspection was conducted on 06/01/2022.Signs of clincial use and no evidence of blood was observed.The aortic cutter was observed to be deployed, with no visual defects observed.Based on the returned condition of the device, the reported failure "premature activation" and "misfire" was not confirmed.The lot # 25161182 history record review was completed.There were ncmrs , rework, or deviations documented for the reported lot number.[(b)(4) on nov 2, 2021 at around 10:30am, moisture was observed in compressed air tubing in the bioline area of eptfe manufacturing.Condensation in air line(s) may be an indication that the air compressor, bmarm id (b)(4), may not have been producing compressed air with a dew point less than or equal to +7 degrees c as required to satisfy the validation acceptance criteria per (b)(4) compressed air distribution system oq/pq protocol, rev b, section 7.7.].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 (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: 14521857
• MDR Text Key: 292828963
• Report Number: 2242352-2022-00460
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2022
• Device Model Number: HST III SYSTEM (3.8MM)
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25161182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 66 KG