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

Model Number	HS-3045
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure, hst iii seal (4.5mm) proximal seal did not come out of the delivery system.A new device was brought out, the operation was successfully completed, and there are no problems with the patient.
Additional Manufacturer Narrative
Trackwise id (b)(4).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.
Additional Manufacturer Narrative
Trackwise # (b)(4).The device was returned to the factory for evaluation on 06/22/2023.An investigation was conducted on (b)(6) 2023.A visual inspection was conducted.Signs of clinical use and no evidence of blood were observed on the device.The delivery device was returned outside the loading device.The seal was observed to be inside the loading device in a partially folded state.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.The blue slide lock was observed to be on and the white plunger was not depressed.Measurements of the delivery device were taken; the inner diameter was measured at 0.197 inches, the outer diameter was measured at 0.22 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 "activation problem" was not confirmed, however the analyzed failure "fitting problem", was confirmed.The lot # 3000248143 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: 17192322
• Report Number: 2242352-2023-00509
• Device Sequence Number: 12201091
• Product Code: DXC
• UDI-Device Identifier: 00607567700307
• UDI-Public: 00607567700307
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K130382
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2023

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: 06/10/2023
• Device Model Number: HS-3045
• Device Catalogue Number: HS-3045
• Device Lot Number: 3000248143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2023
• Supplement Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown