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

Catalog Number C-HS-3045

Device Problem Malposition of Device (2616)

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

Event Date 09/03/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6) 2015 01:32 pm (gmt-4:00) added by (b)(6) ((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.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 before a coronary artery bypass procedure, the heartstring iii proximal seal delivery system was pressed, however the seal was unable to be set properly.It was observed that the thread and wire were entangled.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(6).The device was returned to the factory for evaluation.Blood was not observed in the delivery tube.Slight evidence of blood was observed on the device indicating clinical use.The slide lock was engaged.The plunger was not depressed on the delivery device.The seal and tension spring assembly remained in the loading device.The following measurements were taken; the inner delivery tube diameter was measured as [.198] in.The outer diameter was measured at [.22] in.The length of the delivery tube was measured at [2.50] in.The values recorded were within the tolerance specifications.Based upon the received condition of the device, the reported complaint for failure to load was confirmed.The root cause is undetermined because the event occurred during the use of the device and the procedural operation is unavailable for our review.Specific actions for this failure mode are being managed and documented in the maquet corrective and preventive action (capa) system.Internal complaint number trackwise #(b)(4).

Event Description

The hospital reported that before a coronary artery bypass procedure, the heartstring iii proximal seal delivery system was pressed, however the seal was unable to be set properly.It was observed that the thread and wire were entangled.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• Brand Name: HEARTSTRING 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: 5131532
• MDR Text Key: 27939990
• Report Number: 2242352-2015-01141
• 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: Physician
• Type of Report: Followup
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2016
• Device Catalogue Number: C-HS-3045
• Device Lot Number: 25113836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2015
• 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