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

Catalog Number C-HSK-3038

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 03/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure, hs iii proximal seal system 3.8mm seal was not loaded properly.Tech forgot to let go (step 3) when loading the device and the heartstring was left in it's housing.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure, hs iii proximal seal system 3.8mm seal was not loaded properly.Tech forgot to let go (step 3) when loading the device and the heartstring was left in it's housing.A replacement device was used to complete the procedure.

Manufacturer Narrative

(b)(4).The device was returned to the factory for evaluation.Although the hospital reported that the event occurred during preparation, signs of clinical usage and evidence of blood were observed.A visual inspection was conducted.The delivery device was returned outside the loading device.The seal was returned outside both the loading device and the delivery device.The loading device casing was observed to be detached/broken apart with blood on the casing.The blue slide lock was dis-engaged and the plunger was fully depressed on the delivery device.Blood was observed on the blue slide lock and plunger.No blood was observed in the delivery tube.The seal and tension spring assembly were observed to be intact with no cracks or delamination.Blood was observed on the seal.The following measurements were taken; the inner delivery tube diameter was measured as 0.197 in.The outer diameter was measured at 0.223 in.The length of the delivery tube was measured at 2.52 in.The values recorded were within the tolerance specifications.Based upon the received condition of the device, the reported complaint for "fitting problem" was unable to be confirmed, but was confirmed for the analyzed failure mode "break".The dhr was reviewed for the hs device subassembly.All the test results meet the specifications and results.There were no non-conformities observed.

• 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
• MDR Report Key: 7470638
• MDR Text Key: 106970736
• Report Number: 2242352-2018-00401
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: K080169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-HSK-3038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Device Age: YR
• Date Manufacturer Received: 07/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 82