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

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

Device Problems Fitting Problem (2183); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2019

Event Type  malfunction  

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.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 discarded.

Event Description

The hospital reported that during a coronary artery bypass procedure using hs iii proximal seal, when the delivery device was pulled out from the main body of the delivery system.According to the normal procedure, the proximal seal was missing.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Event Description

The hospital reported that during a coronary artery bypass procedure using hs iii proximal seal, when the delivery device was pulled out from the main body of the delivery system according to the normal procedure, the proximal seal was missing.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).

• 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: 9134931
• MDR Text Key: 185070224
• Report Number: 2242352-2019-01075
• 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
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HST III SEAL (4.5MM), 5-PACK
• Device Catalogue Number: HSK-3045
• Device Lot Number: 25146430
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1