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

Catalog Number 0684-00-0549-02

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Aortic Dissection (2491)

Event Date 09/25/2016

Event Type  Injury  

Manufacturer Narrative

The customer indicated that the device is not returning to the manufacturer and we're unable to complete an evaluation on the affected product.If additional information is provided or the product becomes available a supplemental report with our additional findings will be provided.(b)(4).

Event Description

The iab catheter was inserted in a patient with ami, the surgeon was unable to pass through the sheath and pushed harder causing aortal dissection.Compression applied for 90 minutes which stopped the bleeding.Intra-aortic balloon therapy was discontinued.

Manufacturer Narrative

Date was inadvertently not entered in the initial mdr.Date: (b)(6) 2016.

Event Description

The iab catheter was inserted in a patient with ami, the surgeon was unable to pass through the sheath and pushed hardercausing aortal dissection.Compression applied for 90 minutes which stopped the bleeding.Intra-aortic balloon therapy was discontinued.

• Brand Name: YAMATO PLUS-R 7.5FR. 35CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 6052380
• MDR Text Key: 58244239
• Report Number: 2248146-2016-00086
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2019
• Device Catalogue Number: 0684-00-0549-02
• Device Lot Number: 3000023550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 09/29/2016
• Date Device Manufactured: 02/11/2016
• 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 Outcome(s): Required Intervention