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

Catalog Number C-HSK-3038

Device Problems Improper or Incorrect Procedure or Method (2017); Activation, Positioning or Separation Problem (2906)

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 3.8 mm seal was loaded correctly, but when surgeon attempted to deploy into the aorta, the seal stayed in the delivery tube.The surgeon suggested it may have been user error.The hospital did not report any patient effects.Related to complaints (b)(4).

Manufacturer Narrative

(b)(4).The device was returned to the factory for evaluation.Signs of clinical use and evidence of blood were observed.The delivery device was returned outside the loading device.The seal and tension spring assembly remained in the delivery tube with the seal extended outside the tube.The seal was fully opened.No cracks/delamination was observed on the seal.Blood was visible on the seal.The blue slide lock was did-engaged and the white plunger was fully depressed on the delivery device.Blood was visible in the delivery device indicating that there was attempt to deploy the device into the aorta.Based on the received condition of the device we were not able to measure the delivery tube dimensions.The complaint for the reported failure "failure to deploy" was not confirmed.

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 3.8mm seal was loaded correctly, but when surgeon attempted to deploy into the aorta, the seal stayed in the delivery tube.The surgeon suggested it may have been user error.The hospital did not report any patient effects.Related to complaints (b)(4).

Manufacturer Narrative

(b)(4).Updated the event description to clarify.

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 3.8mm seal was loaded correctly, but when surgeon attempted to deploy into the aorta, the seal stayed in the delivery tube.The surgeon suggested it may have been user error.The hospital did not report any patient effects.Related to complaints (b)(4).Additional information 03/08/2017: there are a total of 5 complaints.

• 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: 6305616
• MDR Text Key: 66867945
• Report Number: 2242352-2017-00103
• 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,Followup
• Report Date: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2017
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25129584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2016
• 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