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

Model Number 8119

Device Problems Difficult To Position (1467); Product Quality Problem (1506); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2015

Event Type  Injury  

Manufacturer Narrative

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 when the left ventricular (lv) lead was being placed, this catheter was used along with a cannulating catheter.There was some difficulty experienced in moving the cannulating catheter.The physician believed it was due to the delivery value and the value was cut to insert the catheter into the delivery system.Continued difficulty was experienced with moving the catheter into the delivery and when the catheter was removed from the delivery there was a unknown object seen on x-ray.This object was unable to be removed and was left in the patient.The source of the object is unknown.It was reported that the accessories were removed and believed to be whole with no missing parts.No adverse patient effects were reported.Another delivery system was successfully used.Additional information was received that the information and images were reviewed by boston scientific's medical safety physician.It was determined that part of a catheter does remain inside of the patient.Anticoagulation therapy was recommended, if not already in place.From the available information it appears to be a procedure related event occurring while handling the viking catheter and its related accessories differently as reported in the instruction for use.No further complications have been reported.

• 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: 5419637
• MDR Text Key: 37778480
• Report Number: 2124215-2015-15211
• 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: 10/08/2015

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: Health Professional
• Device Expiration Date: 04/14/2017
• Device Model Number: 8119
• 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: 10/08/2015
• Initial Date FDA Received: 02/09/2016
• 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