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

Catalog Number C-HSK-3043

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 11/22/2017

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 4.3mm seal was already deployed.The right button was already pushed in.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.A visual inspection was conducted.Signs of clinical use and slight evidence of blood were observed on the loading device.The delivery device was returned inside the loading device the blue slide lock was dis-engaged and the white plunger was fully depressed on the delivery device.The delivery device was removed from the loading device.The seal and tension spring assembly was remained in the loading device.The seal was visible in the loading device window.The tension spring assembly and the seal were removed from the loading device.A microscopic inspection was conducted.No cracks or delamination was observed on the seal.The following measurements of the delivery tube were taken : the inner delivery tube diameter was measured at 0.198 inches., the outer diameter was measured at 0.215 inches.The length of the delivery tube was measured at 2.52 inches.Based on the results of the investigation, due to confirmed "premature deployment" it resulted in the analyzed failure "fitting problem" being confirmed.

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure, hs iii proximal seal system 4.3mm seal was already deployed.The right button was already pushed in.A replacement device was used to complete the procedure.There was no patient involvement.

• 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: 7124370
• MDR Text Key: 95530559
• Report Number: 2242352-2017-01168
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2018
• Device Catalogue Number: C-HSK-3043
• Device Lot Number: 25134515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2017
• 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