MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HEARTSTRING III PROXIMAL SEAL; CLAMP, VASCULAR

Model Number	HS-3045
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Tw 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 or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure the hst iii seal (4.5mm), 5-pack failed to load properly.The blue slide lock was not released and the white plunger was not depressed.The only delay was opening and preparing another device.No patient injury since no patient contact.
Additional Manufacturer Narrative
Trackwise#: (b)(4).The device was returned to the factory fore evaluation on 07/11/2023.An investigation was conducted on 07/19/2023.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The delivery device was returned outside the loading device with the white plunger not depressed and the blue safety lock off, which prevents the white plunger from being depressed.The seal and tension spring assembly was observed in the loading device.A mechanical evaluation was conducted.The seal and tension spring assembly was removed from the loading device with no physical or visual difficulties observed.There were no visual defects observed on the intact seal, no cracks or delamination was observed.Measurements of the delivery device were taken; the inner diameter was measured at 1.95 inches, the outer diameter was measured at 0.219 inches (rm2036883).The length of the delivery tube was measured at 2.47 inches (mcv00004217).The measurement values recorded for the delivery tube were within the tolerance specifications.Based on the returned condition of the device as well as the evaluation results, the reported failure "fitting problem" was confirmed.The lot # 3000261689 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.
Event or Problem Description
N/a.

• Brand Name: HEARTSTRING III PROXIMAL SEAL
• Common Device Name: 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: 17432495
• Report Number: 2242352-2023-00614
• Device Sequence Number: 15688952
• Product Code: DXC
• UDI-Device Identifier: 00607567700307
• UDI-Public: 00607567700307
• Combination Product (Y/N): N
• Initial Reporter State: TN
• PMA/510(K) Number: K130382
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/23/2023
• Device Model Number: HS-3045
• Device Catalogue Number: HS-3045
• Device Lot Number: 3000261689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2023
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 100 KG