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

Catalog Number C-HSK-3043

Device Problem Device Difficult to Setup or Prepare (1487)

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

Event Date 10/21/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4) 2015 09:06 am (gmt-5:00) added by (b)(4): the device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.(b)(4) 2015 03:48 pm (gmt-5:00) added by (b)(4): 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.A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 4.3mm failed to load properly.The hospital did not report any patient effects.

Manufacturer Narrative

On 01/19/2016 11:39 am (gmt-5:00) added by (b)(6): the device was returned to the factory for evaluation.Evidence of clinical use was observed.Blood was not observed on the device or in the delivery tube.The slide lock was dis-engaged with the plunger fully depressed on the delivery device.The seal and tension spring assembly remained inside the loading device.The following measurements were taken; the inner delivery tube diameter was measured as [.198] in.The outer diameter was measured at [.221] in.The length of the delivery tube was measured at [2.50] in.The values recorded were within the tolerance specifications.Based on the received condition of the device, the reported complaint for failure to load was confirmed.Specific actions for this failure mode are being managed and documented in the maquet corrective and preventive action (capa) system.(b)(4).

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 4.3mm failed to load properly.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: 5221535
• MDR Text Key: 31365328
• Report Number: 2242352-2015-01263
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2016
• Device Catalogue Number: C-HSK-3043
• Device Lot Number: 25118678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2015
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2015
• 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
• Patient Age: 42 YR