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

Model Number 7074

Device Problems Difficult To Position (1467); Material Integrity Problem (2978)

Patient Problems Low Blood Pressure/ Hypotension (1914); Heart Failure (2206)

Event Date 06/13/2017

Event Type  Injury  

Manufacturer Narrative

The catheter was discarded and will not be returned.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that during the implant procedure, it was noted that this catheter did not have adequate support and it was not able to reach the target vessel.During the procedure, the patient experienced sudden heart failure and both the patient's blood pressure and blood oxygen decreased.Medical intervention was performed to relieve the patient's symptoms and the procedure was stopped.The implant procedure will be completed the next day.No additional adverse patient effects were reported.

• Brand Name: ACUITY CATHETER
• Type of Device: GUIDE CATHETER
• Manufacturer (Section D): EXTERNAL MANUFACTURER
• Manufacturer (Section G): EXTERNAL MANUFACTURER
• Manufacturer Contact: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 6687096
• MDR Text Key: 79069646
• Report Number: 2124215-2017-11125
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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: 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2018
• Device Model Number: 7074
• Other Device ID Number: ACUITY BREAK-AWAY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/14/2017
• 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