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

Catalog Number 0684-00-0549-01

Device Problem Difficult to Insert (1316)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/22/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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.Complaint record id # (b)(4).

Event Description

It was reported that during insertion of the intra-aortic balloon (iab) the sheath could not be inserted.The customer used a sheath from a different insertion kit to continue therapy.There was no patient harm or adverse event reported.

Manufacturer Narrative

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.Reference complaint # (b)(4).H3 other text: device not returned.

Event Description

It was reported that during insertion of the intra-aortic balloon (iab) the sheath could not be inserted.The customer used a sheath from a different insertion kit to continue therapy.There was no patient harm or adverse event reported.

• Brand Name: YAMATO PLUS-R 7.5FR. 30CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• MDR Report Key: 11673454
• MDR Text Key: 245805100
• Report Number: 2248146-2021-00229
• 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
• Type of Report: Initial,Followup
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2021
• Device Catalogue Number: 0684-00-0549-01
• Device Lot Number: 3000076745
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2021
• Patient Sequence Number: 1