MAUDE Adverse Event Report: MAQUET CV HS III PROXIMAL SEAL SYTEM 4.3MM; CLAMP, VASCULAR

Catalog Number C-HSK-3043

Device Problem Failure to Fire (2610)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/11/2019

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 been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 4.3mm seal stayed in the holster.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

The hsk device was returned to the factory for evaluation.Signs of clinical use and no evidence of blood were observed.A visual inspection was conducted.The delivery device was returned inside the loading device with the tension spring assembly positioned on top of the delivery tube.The delivery device was removed from inside the loading device.The seal and tension spring assembly remained inside the loading device.The slide lock was engaged.The plunger was partially depressed on the delivery device.The seal was taken out from the loading device for inspection.The seal was in a partial taco position.No crack/delamination of seal was observed.No other failures were observed.The following measurements were taken; the inner delivery tube diameter was measured at.197 in.The outer diameter was measured at.220 in.The length of the delivery tube was measured at 2.49 in.The values recorded were within the tolerance specifications.Based upon the received condition of the device, the reported failure mode ¿fitting problem¿ and analyzed failure mode ¿premature deployment" was confirmed.

Event Description

Summary: the hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 4.3mm seal stayed in the holster.(failed to load) a replacement device was used to complete the procedure.The hospital did not report any patient effects.

• Brand Name: HS III PROXIMAL SEAL SYTEM 4.3MM
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8403273
• MDR Text Key: 138708254
• Report Number: 2242352-2019-00270
• 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: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: C-HSK-3043
• Device Lot Number: 25136863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Date Manufacturer Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1