MAUDE Adverse Event Report: DATASCOPE FAIRFIELD LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0474

Device Problem Aspiration Issue (2883)

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

Event Date 12/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The product is promised for return but has not yet been received.As a result, we are unable to complete an evaluation.We continue our good faith efforts for the return of the product.A supplemental report will be provided if new information becomes available.(b)(4).

Event Description

It was reported that the facility was unable to aspirate through the inner lumen of the intra aortic balloon.The patient was given additional heparin and the inner lumen was able to be cleared.

Manufacturer Narrative

The product is promised for return but has not yet been received.As a result, we are unable to complete an evaluation.We continue our good faith efforts for the return of the product.A supplemental report will be provided if new information becomes available.(b)(4).Supplemental: correction.

Event Description

It was reported that the facility was unable to aspirate through the inner lumen of the intra aortic balloon.The patient was given additional heparin and the inner lumen was able to be cleared.

• Brand Name: LINEAR 7.5 FR. 34CC IAB
• 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: 6267928
• MDR Text Key: 65453096
• Report Number: 2248146-2017-00004
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/20/2017,02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3000026543
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/20/2017
• Device Age: YR
• Initial Date Manufacturer Received: 12/28/2016
• Initial Date FDA Received: 01/20/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/22/2017
• 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
• Patient Age: 73 YR