MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HSK III SYSTEM; CLAMP, VASCULAR

Model Number HST III SYSTEM (4.3MM)

Device Problems Filling Problem (1233); Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2019

Event Type  malfunction  

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.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.Device not returned.

Event Description

The hospital reported that during a coronary artery bypass procedure, hst iii system (4.3mm) umbrella could not be loaded normally.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

H6 correction: device codes changed from "filling problem" to "fitting problem".Internal complaint number: (b)(4).An investigation was conducted on 10/22/2019.The device was returned to the factory for evaluation.No evidence of blood was observed.The device as returned was unable to be evaluated for position of seal and tension spring assembly as the delivery device and the loading device were not returned for evaluation.Only the seal with the tension spring assembly was returned.The seal was in a folded orientation indicating that the seal was tried to load in the delivery device.The seal was observed to be cracked.Two photographs were provided by the customer.Photographic inspections were performed.The first picture was blurry.The loading device and the aortic cutter could be seen.The seal with the tension spring assembly was observed inside the loading device.There was no evidence of blood observed.The second picture was a close up of the loading device widow.The seal was observed to be moved away from its original position indicating an attempt to load the seal in the delivery device.Based on the photographic inspection and the returned seal, the complaint was confirmed for the reported failure mode " fitting problem" and the analyzed failure mode "crack".

Event Description

The hospital reported that during a coronary artery bypass procedure, hst iii system (4.3mm) umbrella could not be loaded normally.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• Brand Name: HSK III SYSTEM
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8821659
• MDR Text Key: 152048355
• Report Number: 2242352-2019-00848
• 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: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2020
• Device Model Number: HST III SYSTEM (4.3MM)
• Device Catalogue Number: HSK-3043
• Device Lot Number: 25145346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 67