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

Catalog Number 0684-00-0514

Device Problems Unraveled Material (1664); Failure to Deliver (2338)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/16/2017

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.We continue our efforts to follow up with the customer for its return.(b)(4).

Event Description

It was reported that on (b)(6)2017, the intra-aortic balloon (iab) catheter was inserted in the ami patient.During insertion, it was noted that the iab catheter was unable to be delivered due to the sheath unwrapping.Another iab catheter was used to continue procedure.There was no patient injury reported.

Manufacturer Narrative

Although good faith efforts have been attempted to retrieve the device, the device was not returned by the customer and so could not be evaluated.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Complaint # (b)(4).

Event Description

It was reported that on (b)(6) 2017, the intra-aortic balloon (iab) catheter was inserted in the ami patient.During insertion, it was noted that the iab catheter was unable to be delivered due to the sheath unwrapping.Another iab catheter was used to continue procedure.There was no patient injury 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: 6693355
• MDR Text Key: 79584163
• Report Number: 2248146-2017-00080
• 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: 08/08/2017

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: No Information
• Device Expiration Date: 02/02/2019
• Device Catalogue Number: 0684-00-0514
• Device Lot Number: 3000023364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Initial Date Manufacturer Received: 06/19/2017
• Initial Date FDA Received: 07/07/2017
• Supplement Dates Manufacturer Received: 07/20/2017
• Supplement Dates FDA Received: 08/08/2017
• Date Device Manufactured: 02/02/2016
• 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