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

Catalog Number C-HS-3045

Device Problems Positioning Failure (1158); Fluid/Blood Leak (1250)

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

Event Date 02/17/2016

Event Type  malfunction  

Manufacturer Narrative

The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.(b)(4).

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal did not deploy properly and blood leaked from the seal.A replacement device was used to complete the procedure.The hospital did not report any patient effects.The product is returning.Although the customer loaded the seal into the delivery device by following the procedure, the seal was not properly deployed and blood leaked from the seal.Another product was used to complete the procedure.The surgery was prolonged in 5 minutes.No patient injury was reported.Mkjj sale rep asked for the patient information of gender, age, weight etc., but the hospital didn't release the patient information under the patient policy.

Manufacturer Narrative

(b)(4).The device was returned to maquet for evaluation.Signs of clinical use and evidence of blood were observed.Blood was present in the delivery device, indicating deployment in to the aorta.The slide lock was not engaged and the plunger was fully depressed.The seal was returned outside the device in a fully unraveled state.The tension spring was outside the delivery device and the tether was cut.No defects were observed to the cutter, loading device or delivery device.The tube was unable to be measured due to the presence of blood in the delivery device.The seal was unable to be evaluated for ¿leak¿ as it was returned fully unraveled.The device was unable to be evaluated for failure to deploy because the device was returned in a condition showing proper deployment.Based on the condition of the device as returned, the complaint was unable to be confirmed for the reported failure ¿failure to deploy¿.The state in which the seal was returned is expected.The seal was deployed in the aorta, thus the blood in the delivery device and on the seal.The blue tether was cut to unravel and remove the seal from the aorta as detailed in the instructions for use.We therefore cannot confirm the reported failure "leak" due to unraveled material.The device history record was reviewed.The records show the batch passed final inspection and met all required specifications.

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal did not deploy properly and blood leaked from the seal.A replacement device was used to complete the procedure.The hospital did not report any patient effects.The product is returning.Although the customer loaded the seal into the delivery device by following the procedure, the seal was not properly deployed and blood leaked from the seal.Another product was used to complete the procedure.The surgery was prolonged in 5 minutes.No patient injury was reported.Mkjj sale rep asked for the patient information of gender, age, weight etc., but the hospital didn't release the patient information under the patient policy.

• 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: 5637993
• MDR Text Key: 45001495
• Report Number: 2242352-2016-00435
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2016
• Device Catalogue Number: C-HS-3045
• Device Lot Number: 25119439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2016
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 04/12/2016
• Initial Date FDA Received: 05/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2015
• 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