MAUDE Adverse Event Report: DATASCOPE FAIRFIELD TRANS-RAY 7FR. 40CC IAB - JAPAN; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0514

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 02/10/2019

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.(b)(4).

Event Description

It was reported that an intra-aortic balloon (iab) catheter was inserted in ami(acute myocardial infarction) patient and during pci(percutaneous coronary intervention), iab migration to abdomen was noted.The surgeon tried to adjust the location of the iab, but the catheter migrated repeatedly.The iab was replaced to continue therapy.It was noted that the patient systolic blood pressure was about 70 mmhg in general.Mild tortuosity, moderate sclerosis and mild calcification were noted in the patient vessel.No patient injury was reported.

• Brand Name: TRANS-RAY 7FR. 40CC IAB - JAPAN
• 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: 8403272
• MDR Text Key: 138551781
• Report Number: 2248146-2019-00188
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2019
• Device Catalogue Number: 0684-00-0514
• Device Lot Number: 3000023902
• Was Device Available for Evaluation?: No
• Device Age: YR
• Initial Date Manufacturer Received: 02/12/2019
• Initial Date FDA Received: 03/08/2019
• Was Device Evaluated by Manufacturer?: No
• 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: 0
• Patient Age: 78 YR
• Patient Weight: 72