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

Catalog Number C-HSK-3043

Device Problem Failure to Fire (2610)

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

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 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 a coronary artery bypass procedure, hs iii proximal seal system device did not fire.A replacement device was used to complete the procedure.The hospital did not report any patient effects.Per phone (b)(6) 2017 acct mgr (b)(6) - date of event is unknown.

Manufacturer Narrative

(b)(4).The device was returned to the factory for evaluation.Signs of clinical use and no evidence of blood were observed.The delivery device was returned outside the loading device.The white plunger was not depressed, the slide lock was engaged.The seal and tension spring remained in the loading device.The seal and tension spring were removed from the loading device.The seal was observed to be cracked on the outer side of the coil.The following measurements were taken; the inner delivery tube diameter was measured as.198 in.The outer diameter was measured at.219 in.The length of the delivery tube was measured at 2.50 in.Based on the return condition of the device, the reported complaint for reported failure "failure to deploy" is not confirmed, but confirmed for the analyzed failure "crack seal.".

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system device did not fire.A replacement device was used to complete the procedure.The hospital did not report any patient effects.Per phone may 24, 2017 acct mgr (b)(6) - date of event is unknown.

• 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: 6651308
• MDR Text Key: 78033685
• Report Number: 2242352-2017-00593
• 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
• Type of Report: Initial,Followup
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2018
• Device Catalogue Number: C-HSK-3043
• Device Lot Number: 25130903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2017
• 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