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

Catalog Number 0684-00-0549-02

Device Problems Difficult to Insert (1316); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2019

Event Type  malfunction  

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

Event Description

It was reported during intra-aortic balloon (iab) insertion, the customer experienced resistance while inserting the sheath and the sheath did not insert.The balloon unwrapped while changing to another sheath and could not be used.Another iab (intra-aortic balloon) catheter was used to continue the therapy.There was no reported injury to the patient.

Event Description

It was reported during intra-aortic balloon (iab) insertion, the customer experienced resistance while inserting the sheath and the sheath did not insert.The balloon unwrapped while changing to another sheath and could not be used.Another iab (intra-aortic balloon) catheter was used to continue the therapy.There was no reported injury to the patient.

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.Complaint # (b)(4).

• Brand Name: YAMATO PLUS-R 7.5FR. 35CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 9111162
• MDR Text Key: 189306019
• Report Number: 2248146-2019-00757
• 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: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2019
• Device Catalogue Number: 0684-00-0549-02
• Device Lot Number: 3000036894
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 53