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

Model Number H74916599410

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluated by manufacturer: 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: 2134265-2017-11974 & 2134265-2017-11975.It was reported that perforation which led to a pericardial effusion with tamponade occurred post procedure.The patient was undergoing a left atrial appendage (laa) closure procedure.A watchman ® access system (was) was inserted into the patient and a 27mm watchman ® laa closure device & delivery system was prepped and there were no air bubbles present.The wds was inserted into the was using a wet to wet connection.There was some bleed back from the sheath, but it wasn¿t free flowing.As the physician went up with the wds a column of air was visualized in the was.They stopped the procedure and aspirated the air out of the was.Everything checked again and they went back up with the wds and there was no air noted.The feet of the device started to flower as soon as they came out of the delivery system.At one point while in the appendage, the impulse catheter started to uncurl, but was noticed immediately and released the torque that was on the pigtail and it curled back to its original position.There were no recaptures performed and the procedure was successfully completed.A transesophageal echocardiogram (tee) was performed for about 23 minutes post implant and there was no pericardial effusion.About an hour after the case was over, the patient became hypotensive and an echocardiogram revealed a pericardial effusion with tamponade.A pericardiocentesis was performed and they drained 150ml of fluid from the pericardial sac.The patient was prepped for surgery where they found a small ¿pin¿ sized hole in the laa just below where the feet of the closure device was positioned.An additional 150ml of blood was removed from the pericardial sac and a single stitch was placed in the appendage to seal the hole.The surgery was completed and the patient was in stable condition.The following day the patient was still doing fine.

• Brand Name: IMPULSE 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: 7115974
• MDR Text Key: 94787797
• Report Number: 2134265-2017-12591
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000956
• 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: 11/16/2017

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: H74916599410
• Device Catalogue Number: 16599-41
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2017
• Initial Date FDA Received: 12/13/2017
• 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: 82 YR