MAUDE Adverse Event Report: DATASCOPE FAIRFIELD YAMATO PLUS-R 7.5FR. 30CC IAB - JAPAN; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0549-01

Device Problems Failure to Advance (2524); Material Deformation (2976)

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

Event Date 02/08/2019

Event Type  malfunction  

Manufacturer Narrative

Full event site name is: (b)(6) medical center.The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided, we will send a supplemental report with our additional findings.(b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) insertion, the catheter was unable to be advanced through the sheath.Although an attempt was made to insert by adjusting guide wire, a kink in balloon shaft was found.The iab was replaced and therapy was provided.There was no reported injury to the patient.

• Brand Name: YAMATO PLUS-R 7.5FR. 30CC 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: 8383057
• MDR Text Key: 138136127
• Report Number: 2248146-2019-00145
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2019
• Device Catalogue Number: 0684-00-0549-01
• Device Lot Number: 3000023905
• Was Device Available for Evaluation?: No
• Device Age: YR
• Date Manufacturer Received: 02/08/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/19/2016
• 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: 38