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

Catalog Number C-HSK-3043

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 01/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.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 did not take the proper rolled up shape during the loading.(failed to load properly).A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).The device was returned to the factory for evaluation.Signs of clinical use and no evidence of blood were observed.The delivery device was returned inside the loading device.Delivery device was removed from the loading device.The seal and tension spring assembly remained inside the loading device.The slide lock was engaged.The plunger was not depressed on the delivery device.The seal was taken out from the loading device for inspection.No crack/delamination of seal was observed.The following measurements were taken; the inner delivery tube diameter was measured at.198 in.The outer diameter was measured at.220 in.The length of the delivery tube was measured at 2.50 in.The values recorded were within the tolerance specifications.Based upon the received condition of the device, the reported complaint for the reported failure mode "fitting problem" was confirmed.

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 4.3mm seal did not take the proper rolled up shape during the loading.(failed to load properly).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
• Manufacturer (Section G): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 6777236
• MDR Text Key: 82772854
• Report Number: 2242352-2017-00764
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2017
• Device Catalogue Number: C-HSK-3043
• Device Lot Number: 25128999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1