MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HSK III SYSTEM (3.8MM); CLAMP, VASCULAR

Model Number HST III SYSTEM (3.8MM)

Device Problems Crack (1135); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2019

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.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 system (3.8mm) would not stay coiled once removed from device.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, hst iii system (3.8mm) would not stay coiled once removed from device.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Corrected section: h-3 (device not eval provide code).Trackwise id# (b)(4).The device was returned for evaluation.A follow up report will be submitted when the investigation is completed.

Manufacturer Narrative

Updated sections: a2, g4, g7, h2, h3, h6, h10.Corrected section: h6 device codes - changed to crack.Trackwise # (b)(4).The device was returned to the factory for evaluation on 19dec2019 and investigation was conducted on 23jan2020.Signs of clinical use and no evidence of blood was observed.The delivery device was returned inside the loading device, with the white plunger not depressed and the blue slide lock not engaged.The seal was observed in the loading device window.The delivery device was removed from the loading device.No visual defects were observed on the seal.No cracks were observed on the seal.Based on the returned condition of the device, the reported failure "crack" was not confirmed.

Event Description

The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm) would not stay coiled once removed from device.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• Brand Name: HSK III SYSTEM (3.8MM)
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 9522219
• MDR Text Key: 187261391
• Report Number: 2242352-2019-01425
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2020
• Device Model Number: HST III SYSTEM (3.8MM)
• Device Catalogue Number: HSK-3038
• Device Lot Number: 25144169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 94