MAUDE Adverse Event Report: ARDEN HILLS, MN INTELLANAV¿ MIFI XP TEMPERATURE ABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number M004MR4500K20

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513); Diminished Pulse Pressure (2606)

Event Date 05/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 # 2134265-2017-05791.It was reported that the catheter perforated causing a cardiac tamponade.During a right ventricular outflow tract (rvot) mapping and ablation procedure, an orion and intellanav mifi xp catheter were selected for use.A non-boston scientific steerable sheath was also being used.While mapping in the rvot, one of the catheters perforated.It was unknown which device caused it.It is unclear when the perforation actually occurred.Approximately 3-5 minutes later, the physician first noticed a weak femoral pulse and then the patient's blood pressure started to drop.The patient developed a cardiac tamponade, which could not be drained percutaneously because the bleeding was so perfuse.An electrophysiology (ep) physician was called in to open up the patient's chest and repair the rvot.They found a tear about a 1 cm long in the rvot.The procedure was not completed due to the event.After the procedure, the patient was stable and alert.

• Brand Name: INTELLANAV¿ MIFI XP TEMPERATURE ABLATION CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): ARDEN HILLS, MN; 4100 hamline avenue; st. paul MN 55112
• Manufacturer (Section G): ARDEN HILLS, MN; 4100 hamline avenue; st. paul MN 55112
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6640633
• MDR Text Key: 77554044
• Report Number: 2134265-2017-05793
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020025
• 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: 05/23/2017

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: M004MR4500K20
• Device Catalogue Number: MR4500K2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2017
• Initial Date FDA Received: 06/14/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 74 YR