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

Catalog Number C-HS-3045

Device Problem Device Inoperable (1663)

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

Event Date 04/26/2018

Event Type  malfunction  

Manufacturer Narrative

Internal complaint # trackwise # (b)(4).Autonumber # (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 customer tried to set the device according to the procedure, however, the seal dropped in the loader when the delivery system was pulled out and unable to use.A replacement was used to complete the procedure.No patient injury was reported.

Manufacturer Narrative

(b)(4).The device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use with evidence of blood were observed.The delivery device was outside the loading device when it was returned.The blue slide lock was engaged and the plunger was not pressed on the delivery device.The seal is partially visible from the window of the loading device.Trace of blood was evident at the tip of the plunger of the delivery device.The tension spring assembly and the seal were then pulled out from the loading device for inspection.Microscopic inspection showed the seal intact, without cracks nor delamination.Measurements were taken for the delivery tube.The measurement values recorded for the delivery tube were within the tolerance specifications.Based upon the received condition of the device, and the results of the evaluation, 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 customer tried to set the device according to the procedure, however, the seal dropped in the loader when the delivery system was pulled out and unable to use.A replacement was used to complete the procedure.No patient injury was reported.

• Brand Name: HS III PROXIMAL SEAL
• 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: 7545190
• MDR Text Key: 109500821
• Report Number: 2242352-2018-00494
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K080169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2018
• Device Catalogue Number: C-HS-3045
• Device Lot Number: 25134975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2017
• 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