MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HSK III SEAL (4.5MM); CLAMP, VASCULAR

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

Device Problem Activation Problem (4042)

Patient Problem Blood Loss (2597)

Event Date 05/12/2020

Event Type  Injury  

Manufacturer Narrative

Trackwise id # (b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.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.

Event Description

The hospital reported that during a coronary artery bypass procedure, hst iii seal (4.5mm) did not develop sufficiently.The loading operation of the proximal seal to the delivery system was carried out, and after inserting the delivery system into the aorta (after using the artificial cutter), the aortic opening could not be completely closed by the proximal seal.Because they had seen bleeding, the surgeon decided that it was a malfunction and removed the polymeric seal.After bleeding, the surgeon pressed it with his finger immediately, so much bleeding was gone.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Updated sections: d10, g4, g7, h2, h3, h6, h10.Internal complaint number: (b)(4).The device was returned on 06/23/2020.An investigation was conducted on 07/02/2020.A visual inspection was conducted.Signs of clinical use and slight evidence of blood was observed on the seal.There was slight evidence of blood on the delivery device blue slide lock and plunger as well.The delivery device was returned outside the loading device with the white plunger not depressed and the blue slide lock not disengaged.The tension spring assembly was observed to be inside the delivery tube; however, the tension spring assembly was not fully loaded in the delivery tube with the seal extended outside the tube in an open state the seal and tension spring assembly was removed from the delivery device, with no visual defects, cracks or delamination observed on the seal.Measurements of the delivery tube were taken.The inner diameter was measured at 0.197 in., the outer diameter was measured at 0.218 in.The length of the delivery tube was measured at 2.48 inches.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 but was confirmed for the analyzed failure "fitting problem.".

Event Description

The hospital reported that during a coronary artery bypass procedure, hst iii seal (4.5mm) did not develop sufficiently.The loading operation of the proximal seal to the delivery system was carried out, and after inserting the delivery system into the aorta (after using the artificial cutter), the aortic opening could not be completely closed by the proximal seal.Because they had seen bleeding, the surgeon decided that it was a malfunction and removed the polymeric seal.After bleeding, the surgeon pressed it with his finger immediately, so much bleeding was gone.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• Brand Name: HSK III SEAL (4.5MM)
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 10123976
• MDR Text Key: 194159989
• Report Number: 2242352-2020-00481
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: K130382
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2020
• Device Model Number: HST III SEAL (4.5MM), 5-PACK
• Device Catalogue Number: HS-3045
• Device Lot Number: 25148409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/13/2020
• Initial Date FDA Received: 06/05/2020
• Supplement Dates Manufacturer Received: 06/23/2020
• Supplement Dates FDA Received: 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention