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

Catalog Number 0684-00-0549-02

Device Problems Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2020

Event Type  malfunction  

Manufacturer Narrative

Event site postal code: (b)(6).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.Complaint # (b)(4).

Event Description

It was reported that during the insertion of an intra-aortic balloon (iab), the membrane became unfurled and was unable to be inserted through the sheath.The iab was replaced and therapy was provided.There was no reported injury to the patient.

Event Description

It was reported that during the insertion of an intra-aortic balloon (iab), the membrane became unfurled and was unable to be inserted through the sheath.The iab was replaced and therapy was provided.There was no reported injury to the patient.

Manufacturer Narrative

Additional information: section d - device available for eval? from: yes to no.Section h - evaluation method codes added: device discarded; 4115.Added: historical data analysis; 4109.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 was discarded and not returned.

• Brand Name: YAMATO PLUS-R 7.5FR. 35CC IAB - JAPAN
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 10354985
• MDR Text Key: 201400927
• Report Number: 2248146-2020-00383
• 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: 09/10/2020

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: 07/10/2020
• Device Catalogue Number: 0684-00-0549-02
• Device Lot Number: 3000055039
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/08/2020
• Initial Date FDA Received: 08/03/2020
• Supplement Dates Manufacturer Received: 09/07/2020
• Supplement Dates FDA Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1