MAUDE Adverse Event Report: MAQUET CV HS III PROXIMAL SEAL SYTEM 3.8MM; CLAMP, VASCULAR

Catalog Number C-HSK-3038

Device Problems Fitting Problem (2183); Defective Device (2588)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2019

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.

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 3.8mm failed.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, hs iii proximal seal system 3.8mm failed to fire.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Corrected sections: describe event or problem.Corrected to reflect the correct updated information.Internal complaint # (b)(4).Autonumber # (b)(4).The hsk device was not returned to the factory for evaluation.However, the cutter device was only returned for investigation.Signs of clinical use and evidence of blood were observed.A visual inspection was conducted.Sign of blood was observed on the cutter and needle.The safety lock was disengaged and the actuation button fully depressed inside the tool with the cutter and spiral needle deployed.The needle was observed to be bent.No other failures were observed.Based on the returned condition of the device and the results of the investigation the reported failure mode ¿activation problem; seal¿ was unable to be confirmed but was confirmed for analyzed failure ¿material twisted/bent; needle¿.A certificate of conformance was reviewed for the assembly, aortic utter.The vendor certifies that the product lot meets and conforms to the specifications and requirements applicable.

• Brand Name: HS III PROXIMAL SEAL SYTEM 3.8MM
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8411529
• MDR Text Key: 138893967
• Report Number: 2242352-2019-00296
• 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
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2019
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25143191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Initial Date Manufacturer Received: 02/15/2019
• Initial Date FDA Received: 03/12/2019
• Supplement Dates Manufacturer Received: 05/10/2019
• Supplement Dates FDA Received: 05/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1