MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HST; CLAMP, VASCULAR

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

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 07/23/2019

Event Type  Injury  

Manufacturer Narrative

(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.Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.Device scrapped.

Event Description

The hospital reported that during a coronary artery bypass procedure using hst iii seal.They inserted the heart string as usual and opened the umbrella, but he did not closely contact and could not stop the hemostasis.A replacement device was used to complete the procedure.

Manufacturer Narrative

Corrected sections: b1-changed to adverse event & product problem.B2-changed to required intervention.H1-changed to serious injury.(b)(4).

Event Description

The hospital reported that during a coronary artery bypass procedure using hst iii seal.They inserted the heart string as usual and opened the umbrella, but he did not closely contact and could not stopthe hemostasis.A replacement device was used to complete the procedure.

Event Description

The hospital reported that during a coronary artery bypass procedure using hst iii seal.They inserted the heart string as usual and opened the umbrella, but he did not closely contact and could not stopthe hemostasis.A replacement device was used to complete the procedure.

Manufacturer Narrative

(b)(4).Mdr originally submitted on (b)(6) 2019.Resubmitted per cdrh request from: esg help (b)(6) on (b)(6) 2019, at 4:47 pm, (b)(6) wrote: "hello,  we were notified that cdrh processing system had intermittent issues processing submissions ("adverse_events" and "electronic_submissions" ) from 1pm est on october 9, 2019 to 2pm est on (b)(6) 2019.  cdrh has requested users to resend submissions if you have not received ack3 or ack4 for your submissions sent during this time.The device was discarded.

• Brand Name: HST
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8898765
• MDR Text Key: 154574222
• Report Number: 2242352-2019-00938
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2020
• Device Model Number: HST III SEAL (4.5MM), 5-PACK
• Device Catalogue Number: HS-3045
• Device Lot Number: 25146106
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention