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

Catalog Number C-HSK-3043

Device Problems Sticking (1597); Device Operates Differently Than Expected (2913)

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

Event Date 02/27/2017

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 a coronary artery bypass procedure, hs iii proximal seal system 4.3mm steps 1, 2 and 3 were carried out under optical correct control.Step 4 (removing the charged heartstring applicator tube from the charger using the caged heartstring device) failed: the heartstring device caught in the charger and was stuck in the charger and was thus no longer present in the applicator tube.Manually the device could be recovered, but then no longer correctly inserted into the applicator, so application failed.This problem has arisen for the third time in the application of heartstring over the past 12 months.The hospital did not report any patient effects.

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 inside the loading device.Blood was visible in the delivery device indicating that there was attempt to deploy the device into the aorta.There was blood on the delivery tube as well as on the loading device.The slide lock was disengaged and the plunger was depressed on the delivery device.The delivery device was removed from the loading device.The seal and tension spring assembly was not returned with the device for evaluation.The device as returned was unable to be evaluated for position of the seal.Based on the return condition of the delivery device, measurements were unable to be taken, we are unable to confirm the reported failure "seal did not load properly".

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 4.3 mm steps 1, 2 and 3 were carried out under optical correct control.Step 4 (removing the charged heartstring applicator tube from the charger using the caged heartstring device) failed: the heartstring device caught in the charger and was stuck in the charger and was thus no longer present in the applicator tube.Manually the device could be recovered, but then no longer correctly inserted into the applicator, so application failed.This problem has arisen for the third time in the application of heartstring over the past 12 months.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 4.3 mm steps 1, 2 and 3 were carried out under optical correct control.Step 4 (removing the charged heartstring applicator tube from the charger using the caged heartstring device) failed: the heartstring device caught in the charger and was stuck in the charger and was thus no longer present in the applicator tube.Manually the device could be recovered, but then no longer correctly inserted into the applicator, so application failed.This problem has arisen for the third time in the application of heartstring over the past 12 months.The hospital did not report any patient effects.

• 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: 6437808
• MDR Text Key: 71214495
• Report Number: 2242352-2017-00312
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2017
• Device Catalogue Number: C-HSK-3043
• Device Lot Number: 25129111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2016
• 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 Age: 85 YR
• Patient Weight: 72