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

Catalog Number C-HSK-3038

Device Problem Positioning Failure (1158)

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

Event Date 06/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.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 did not load properly.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).The device was returned to the factory for evaluation.A visual inspection was conducted.Even though it is reported that the event occurred prior to surgery, signs of clinical use and evidence of blood were observed.Blood was observed on the loading device as well as the delivery device.The delivery device was returned inside the loading device.The blue slide lock was engaged and the white plunger was not depressed on the delivery device.The seal and the tension spring assembly was observed in the loading device.The seal was observed to be unraveled in the loading device.The delivery device was removed from the loading device.The seal and tension spring remained inside the loading device.The seal and tension spring assembly was removed from the loading device.The seal was observed to be unraveled at the center of the coil.No other visual defects were observed.The following measurements of the delivery tube were taken : the inner delivery tube diameter was measured at 0.196 inches.The outer diameter was measured at 0.219 inches.The length of the delivery tube was measured at 2.51 inches.The values recorded were within the tolerance specifications.Based upon the received condition of the device, the photos received from the complainant and the results of the evaluation, the reported failure mode "fitting problem" was confirmed.The analyzed failure mode "unraveled seal" was also confirmed.

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure, hs iii proximal seal system did not load properly.The hospital did not report any patient effects.

• 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: 7656696
• MDR Text Key: 113288872
• Report Number: 2242352-2018-00634
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2018
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25135182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 08/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2017
• 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: 70 YR