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

Catalog Number C-HSK-3038

Device Problem Difficult to Advance (2920)

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

Event Date 09/07/2018

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 preparation for a coronary artery bypass procedure, hs iii proximal seal system 3.8mm was unable to be advanced in step 3 of the ifu.The seal did not load properly into the delivery device tube.The device was not used on the aorta.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Internal complaint number: (b)(4).Autonumber: (b)(4).The device was returned to the factory for evaluation.Signs of clinical use was observed.There was no evidence of blood detected.The delivery device was returned within the loading device.The blue slide lock was disengaged and the plunger was un-pressed on the delivery device.The delivery device was pulled out from the loading device for inspection.The seal and tension spring assembly remained inside the loading device.The seal was then pulled out for inspection.Microscopic inspection showed the seal was slightly cracked at the outer edge.The tether on the tension spring remained uncut.The following measurements were taken for the delivery device; the inner delivery tube diameter was measured at.197 in.The outer diameter was measured at.220 in.(b)(4).The length of the delivery tube was measured at 2.51in.(b)(4).The values recorded were within the tolerance specifications.Based on the returned condition of the device and the evaluation results, the reported failure "fitting problem" is confirmed, and the analyzed failure "crack; seal" is confirmed.

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure, hs iii proximal seal system 3.8mm was unable to be advanced in step 3 of the ifu.The seal did not load properly into the delivery device tube.The device was not used on the aorta.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• 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: 7940567
• MDR Text Key: 123205233
• Report Number: 2242352-2018-00986
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: K080169
• 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: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2019
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25139932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Device Age: YR
• Date Manufacturer Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR