MAUDE Adverse Event Report: DATASCOPE FAIRFIELD YAMATO PLUS-R 7.5FR. 35CC IAB - JAPAN; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0549-02

Device Problem Obstruction of Flow (2423)

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

Event Date 09/02/2018

Event Type  malfunction  

Manufacturer Narrative

Distributor name: (b)(4).Product status: the device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.(b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) insertion on an acute coronary syndrome patient (acs), the surgeon found the inner lumen was occluded and unable to measure arterial pressure.It was noted that when the sheath was inserted, the iab became unfurled and difficult to advance through, therefore the surgeon pushed the balloon hard.A kink may have occurred during at this time.The iab was replaced to continue therapy.No patient injury was reported.

• Brand Name: YAMATO PLUS-R 7.5FR. 35CC IAB - JAPAN
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 7919349
• MDR Text Key: 122314549
• Report Number: 2248146-2018-00557
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2019
• Device Catalogue Number: 0684-00-0549-02
• Device Lot Number: 3000038468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 09/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/21/2016
• 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: 72 YR
• Patient Weight: 65