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

Catalog Number C-HSK-3038

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 10/17/2017

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 preparation for a coronary artery bypass procedure, hs iii proximal seal system 3.8mm when removing the delivery device and hs from the loading device, the hs remained.A replacement was used to complete 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 with no evidence of blood were observed.The delivery device was returned outside the loading device.The seal and tension spring assembly remained inside the loading device.The blue slide lock was disengaged and the plunger was not pressed on the delivery device.The tension spring assembly and the seal were removed from the loading device for inspection.Microscopic inspection showed that the seal was intact with no signs of delamination or cracks.The following measurements of the delivery tube were taken; the inner diameter was measured at 0.196 in.The outer diameter was measured at 0.217 in.The length of the delivery tube was measured at 2.50 in.The values recorded were within the tolerance specifications.Based on the returned condition of the device and the results of the investigation, the reported failure mode "fitting problem" was confirmed.

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure, hs iii proximal seal system 3.8mm when removing the delivery device and hs from the loading device, the hs remained.A replacement was used to complete 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
• Manufacturer (Section G): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 7023446
• MDR Text Key: 92508669
• Report Number: 2242352-2017-01058
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2018
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25133454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2017
• 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