MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE IMPULSE GUIDE CATHETERS; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number UNK189

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 04/04/2014

Event Type  Injury  

Event Description

It was reported that a hematoma was noted in the femoral puncture site.The 99% stenosed target lesion was located at the diagonal branch of the left anterior descending artery.During a diagnostic procedure, impulse guide catheter got kinked as the physician was advancing it to the sheath and into the patient's body.A hematoma occurred in the femoral puncture site.The hematoma was treated with medication.The procedure was completed with this device.No further complications were reported and the patient's condition was stable following the procedure.

Manufacturer Narrative

Device evaluated by mfr: the device has not been received for analysis; therefore a failure analysis of the complaint device could not be completed.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

• Brand Name: IMPULSE GUIDE CATHETERS
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3785010
• MDR Text Key: 4440130
• Report Number: 2134265-2014-02345
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: K992142
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2014
• 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): Required Intervention
• Patient Age: 58 YR