MAUDE Adverse Event Report: GUIDANT PUERTO RICO BV ACUITY CATHETER; GUIDE CATHETER

Model Number 8105

Device Problem Human-Device Interface Problem (2949)

Patient Problem Perforation of Vessels (2135)

Event Date 07/12/2016

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 implant procedure the guide wire perforated the coronary sinus as confirmed by echocardiogram and transesophageal echocardiogram (tee).Additionally, a paracentesis tap was done to drain a small amount of fluid and was then able to stabilize the patient in the procedure.No additional adverse patient effects were reported.

• Brand Name: ACUITY CATHETER
• Type of Device: GUIDE CATHETER
• Manufacturer (Section D): GUIDANT PUERTO RICO BV
• Manufacturer (Section G): GUIDANT PUERTO RICO BV
• Manufacturer Contact: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 6048812
• MDR Text Key: 58128073
• Report Number: 2124215-2016-12887
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132914
• 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: 07/12/2016

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 Model Number: 8105
• 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: 07/12/2016
• Initial Date FDA Received: 10/21/2016
• 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
• Treatment: 0292; 4674; D140
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 76 YR