MAUDE Adverse Event Report: EXTERNAL MANUFACTURER ACUITY CATHETER; GUIDE CATHETER

Model Number 8115

Device Problem Human-Device Interface Problem (2949)

Patient Problems Dyspnea (1816); Discomfort (2330); Vascular Dissection (3160)

Event Date 03/30/2016

Event Type  Injury  

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.

Event Description

Boston scientific received information that during placement of this catheter a small coronary sinus dissection was observed.The catheter was withdrawn.The patient was short of breath and uncomfortable.Oxygen and diuretic medications were administered.The procedure was completed and the patient improved after sitting up.

• Brand Name: ACUITY CATHETER
• Type of Device: GUIDE CATHETER
• Manufacturer (Section D): EXTERNAL MANUFACTURER
• Manufacturer (Section G): EXTERNAL MANUFACTURER
• Manufacturer Contact: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 5616346
• MDR Text Key: 43923244
• Report Number: 2124215-2016-05428
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/30/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2018
• Device Model Number: 8115
• Other Device ID Number: ACUITY PRO GUIDING CATHETER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/30/2016
• Initial Date FDA Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention