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

Catalog Number C-HSK-3038

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

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

Event Type  Injury  

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 3.8mm cutter produced a typical aortotomy but when the delivery tube was inserted into the aorta, the surgeon was not able to use the device to push the hs forward into the aorta.He was quite aggressive, breaking the white button off the delivery tube as a result.A replacement device was used to complete the procedure.Then the side-biting clamp applied when that "failed" as well.

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 tension spring assembly remained in the delivery tube with the seal completely extended outside the tube.The extended seal was observed in unfolded/unwrapped state.Blood was visible on the seal.The blue slide lock was engaged and the white plunger was broken.The broken plunger was not returned back.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.Based on the findings and investigation the complaint was not confirmed for the reported failure mode "failure to deploy" but was confirmed for the analyzed failure mode "break".

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 3.8 mm cutter produced a typical aortotomy but when the delivery tube was inserted into the aorta, the surgeon was not able to use the device to push the hs forward into the aorta.He was quite aggressive, breaking the white button off the delivery tube as a result.A replacement device was used to complete the procedure.Then the side-biting clamp applied when that "failed" as well.

• 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: 6397599
• MDR Text Key: 69737901
• Report Number: 2242352-2017-00243
• 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: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2017
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25124868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2016
• 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
• Patient Outcome(s): Other