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

Model Number UNK130

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

Patient Problems Bradycardia (1751); ST Segment Elevation (2059)

Event Date 10/12/2016

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id: 2134265-2016-09829.It was reported the patient experienced bradycardia and st elevation.A left atrial appendage (laa) closure procedure was being performed.A watchman® access system (was) was positioned in the patient with 6fr expo pigtail catheter inside of it.The patient experienced bradycardia and st elevation.Air was noted in the contrast line and it was flushed until it was gone.No intervention was required, the complication resolved within about 10 seconds and the patient was fine.No air was visualized in either the was or the patient.The procedure was continued with this was.A 27mm watchman ® laa closure device was deployed and determined to be too small for the appendage.The device was recaptured and a 30mm watchman ® laa closure device was then successfully implanted.There were no further patient complications reported and the patient¿s status is fine.

• Brand Name: EXPO GUIDE CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6154645
• MDR Text Key: 61732183
• Report Number: 2134265-2016-11725
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992142
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2016
• 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): Other
• Patient Age: 80 YR