MAUDE Adverse Event Report: DATASCOPE FAIRFIELD YAMATO PLUS-R 7.5FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0549-03

Device Problems Difficult to Insert (1316); Failure to Advance (2524); Physical Resistance/Sticking (4012)

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

Event Date 10/09/2018

Event Type  malfunction  

Manufacturer Narrative

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) therapy, the sheath was difficult to insert.However, it was inserted.It was reported it was difficult to advance the intra-aortic balloon (iab) through the supplied sheath and the iab got stuck at the tip of sheath.The intra-aortic balloon (iab) was replaced to continue therapy.There was no reported injury to the patient.

• Brand Name: YAMATO PLUS-R 7.5FR. 40CC IAB
• 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: 8038746
• MDR Text Key: 126715540
• Report Number: 2248146-2018-00631
• 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: Biomedical Engineer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2019
• Device Catalogue Number: 0684-00-0549-03
• Device Lot Number: 3000025563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 10/11/2018
• Initial Date FDA Received: 11/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/14/2016
• 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