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

Model Number H749165993010

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001); No Consequences Or Impact To Patient (2199); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 12/18/2017

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:2134265-2017-13112 & 2134265-2017-13113.It was reported that a perforation and pericardial effusion with tamponade occurred.A left atrial appendage (laa) closure procedure was being performed; vascular access was obtained via the right femoral vein.The transeptal puncture was performed with difficulty due to the tortuous inferior vena cava (ivc).An appendogram showed a multilobar appendage with adequate depth.The la appendage was measured using a transesophageal echocardiography (tee); with a maximum diameter of approximately 22mm and a depth of 30mm.A 27mm watchman ® laa closure device & delivery system (wds) along with a watchman® access system (was) were used.The closure device was deployed and was noted to be deep seated.The closure device was partially recaptured and re-deployed more proximally.A tee showed satisfactory positioning with adequate compression; however, during the tug test the closure device moved proximally causing 4mm of flow.It was deemed that the closure device was undersized and they decided to upsize up to a 30mm closure device.During introduction of the impulse pigtail catheter through the was, the non-bsc exchange wire was noted to have entered the pericardial space cause a perforation to the laa.An echocardiogram revealed a gradual increase of pericardial fluid with tamponade which caused the patient to become hypotensive.A pericardiocentesis was performed with auto transfusion.There was good improvement of hemodynamics after each removal of approximately 80-100ml of blood.Rapid re-accumulation was noted with hemodynamic compromise.Auto transfusion was continued and the patient sent for surgical closure via mid line thoracotomy.The la perforation was successfully ligated and the patient¿s hemodynamics returned to normal.The patient was transferred to the intensive care unit (icu) in stable condition.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the impulse catheter was advanced all the way through the was and exited the tip of the was.However, it was also confirmed through imaging that the non-bsc exchange wire most likely caused the perforation.

• 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: 7181804
• MDR Text Key: 96952491
• Report Number: 2134265-2018-00070
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: ZA
• PMA/PMN Number: K000956
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/18/2017

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: H749165993010
• Device Catalogue Number: 16599-301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2017
• Initial Date FDA Received: 01/11/2018
• Supplement Dates Manufacturer Received: 02/05/2018
• Supplement Dates FDA Received: 02/16/2018
• 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: 84 YR