MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HSK III SYSTEM (4.3MM); CLAMP, VASCULAR

Model Number HST III SYSTEM (4.3MM)

Device Problem Fitting Problem (2183)

Patient Problem No Patient Involvement (2645)

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

(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, hst iii system (4.3mm) (seal) coiled piece came out of the device after step 2 when they were removing it.A replacement device was used to complete the procedure.No patient involvement.

Manufacturer Narrative

Internal complaint number: (b)(4).The lot # 25154949 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.

Event Description

The hospital reported that during a coronary artery bypass procedure, hst iii system (4.3mm) (seal) coiled piece came out of the device after step 2 when they were removing it.A replacement device was used to complete the procedure.No patient involvement.

• Brand Name: HSK III SYSTEM (4.3MM)
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 11332972
• MDR Text Key: 231998724
• Report Number: 2242352-2021-00132
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607567700321
• UDI-Public: 00607567700321
• 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
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2021
• Device Model Number: HST III SYSTEM (4.3MM)
• Device Catalogue Number: HSK-3043
• Device Lot Number: 25154949
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1