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 02/13/2017

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 second heartstring was opened and loaded for use following failure of the first heartstring attempt.The same problem then occurred where the heartstring could not be pushed into the aorta using the white button.As a result, the surgeon applied the side-biting clamp and sewed the anastomosis in that fashion.The hospital did not report any patient effects.Note--after reviewing the incident with the nursing team, it was realized that the safety had not been released on either heartstring and that is why the surgeon could not insert the loaded seal into the aorta on either occasion.

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 was returned separately in an unraveled state with the tether missing.Traces of blood were observed on the seal and loading device.The blue slide lock was 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 delivery device we were not able to measure the delivery tube dimensions.Based on the returned condition of the device and the evaluation results we were not able to find any failures with the device.The device was used according to the procedure.There was no malfunction observed.As per the instructions per use, blood within the delivery device is an indication of proper insertion of seal into the aorta via the hole created by the cutter.The ifu instructs the user that while securing the seal stem, cut one end of the tether and remove the tension spring with the remaining tether.Hold the seal tem right below the anchor tab and gently pull the seal stem to unravel and remove the proximal seal.Visually confirm the complete removal of the heart string proximal seal by the presence of an angled cut at the end of the unrevealed seal.

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 3.8mm second heartstring was opened and loaded for use following failure of the first heartstring attempt.The same problem then occurred where the heartstring could not be pushed into the aorta using the white button.As a result, the surgeon applied the side-biting clamp and sewed the anastomosis in that fashion.The hospital did not report any patient effects.Note--after reviewing the incident with the nursing team, it was realized that the safety had not been released on either heartstring and that is why the surgeon could not insert the loaded seal into the aorta on either occasion.

Manufacturer Narrative

(b)(4).

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 3.8mm second heartstring was opened and loaded for use following failure of the first heartstring attempt.The same problem then occurred where the heartstring could not be pushed into the aorta using the white button.As a result, the surgeon applied the side-biting clamp and sewed the anastomosis in that fashion.The hospital did not report any patient effects.Note--after reviewing the incident with the nursing team, it was realized that the safety had not been released on either heartstring and that is why the surgeon could not insert the loaded seal into the aorta on either occasion.

• 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: 6397583
• MDR Text Key: 69737728
• Report Number: 2242352-2017-00242
• 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,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: 04/19/2017
• 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