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

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

Device Problems Failure to Unfold or Unwrap (1669); Activation Problem (4042)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2020

Event Type  malfunction  

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.

Event Description

The hospital reported that during a coronary artery bypass procedure using hst iii seal (4.5mm.In cabg (opcab), a poor deployment of the proxima seal occurred.They performed the loading operation of the proxima centauri to the delivery system (it was normal), and tried to insert the proxima centauri into the aorta by pressing the plunger, but the proxima centauri did not extend and expand.It was not fully deployed and the aortic opening could not be completely closed by the proxima centauri.The surgeon decided that there was a problem and removed the proxima centauri.· as a concrete measure he used another heart string iii (hs-3045) while holding the opening (tomy) of the aorta with his finger to stop bleeding.Central anastomosis without any problem in the second use.They were able to perform the technique.It seems that there was almost no bleeding, and the central anastomosis was successfully performed.The hospital did not report any patient effects.

Manufacturer Narrative

Corrected section: h6 - device code changed to failure to unfold or unwrap.Trackwise # (b)(4).The lot # 25151015 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 on 30nov2020 for evaluation and investigated on 14dec2020.The loading device was not returned for investigation.A visual inspection was conducted.Signs of clinical use with slight evidence of blood was observed on the seal and the delivery tube.The blue slide lock was dis-engaged and the plunger was completely depressed.The anchor and tension spring assembly remained inside the delivery device in the pre-deployed position.The seal was extended outside the tube and did not appear to be folded.The seal was inspected.Microscopic inspection showed the tether remained uncut and attached to the seal and tension spring.Dimensions of the delivery tube were taken.The inner diameter was measured at 0.197 inches, the outer diameter was measured at 0.220 inches.The length of the delivery tube was measured at 2.500 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 "failure to unfold or unwrap" was not confirmed.

Event Description

The hospital reported that during a coronary artery bypass procedure using hst iii seal (4.5mm.In cabg (opcab), a poor deployment of the proxima seal occurred.They performed the loading operation of the proxima centauri to the delivery system (it was normal), and tried to insert the proxima centauri into the aorta by pressing the plunger, but the proxima centauri did not extend and expand.It was not fully deployed and the aortic opening could not be completely closed by the proxima centauri.The surgeon decided that there was a problem and removed the proxima centauri.As a concrete measure he used another heart string iii (hs-3045) while holding the opening (tomy) of the aorta with his finger to stop bleeding.Central anastomosis without any problem in the second use.They were able to perform the technique.It seems that there was almost no bleeding, and the central anastomosis was successfully performed.The hospital did not report any patient effects.

• Brand Name: HSK III SEAL (4.5MM), 5-PACK
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 10948882
• MDR Text Key: 220245109
• Report Number: 2242352-2020-01064
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2021
• Device Model Number: HST III SEAL (4.5MM), 5-PACK
• Device Catalogue Number: C-HS-3045
• Device Lot Number: 25151015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 12/04/2020
• Supplement Dates Manufacturer Received: 11/30/2020
• Supplement Dates FDA Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1