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 Pericardial Effusion (3271)

Event Date 12/15/2017

Event Type  Injury  

Manufacturer Narrative

It is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mfr: 2134265-2017-13039, 2134265-2017-13038.It was reported that a pericardial effusion occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman® access system (was) along with an impulse pigtail catheter was inserted into the patient with an anterior approach on a ridge between an anterior and posterior lobe.Upon insertion of the a 21mm watchman ® laa closure device & delivery system (wds), the tip of the was fell into the posterior lobe.No effusion was noted at that time.The closure device was removed and they re-introduced the impulse pigtail catheter to reposition the was.At this time, the impulse pigtail catheter was deep seated in the anterior lobe not the was.Upon injection with contrast through the pigtail an effusion was noted.A pericardial tap was performed and 100ml of blood was removed.The drain stayed inside the patient until the following day.The patient¿s vital signs remained stable through the entire procedure.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7214670
• MDR Text Key: 98049790
• Report Number: 2134265-2018-00482
• 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: 01/10/2018

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: UNK189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2018
• Initial Date FDA Received: 01/24/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR