MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) NAVISTAR¿ DS ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number D-1201-19-S

Device Problem Unintended Movement (3026)

Patient Problems Perforation (2001); Cardiac Tamponade (2226)

Event Date 05/12/2015

Event Type  Injury  

Event Description

It was reported that an (b)(6) male patient, underwent an atrial fibrillation procedure with a navistar¿ ds electrophysiology catheter and suffered cardiac tamponade which required pericardiocentesis and extended hospitalization.The patient was reported to be in stable condition at the time the complaint was reported.The physician¿s opinion regarding the cause of this adverse event is that he perforated the right ventricle when repositioning the non biosense quad.Brk needle and agilis sheath were used during the procedure.Activated clotting time was greater than 400 seconds.This event is being reported conservatively since we cannot rule out that the bwi catheter may have been involved in the injury.

Manufacturer Narrative

Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such,the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.B) as lot # 17196050m was provided, the device history record(s) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).Bwi concomitant products used: product name: carto® 3 system, us catalog#: fg540000, serial #: (b)(4); product name: stockert 70 rf generator, us catalog#: s7001, serial #: (b)(4); non-bwi products used: striker polaris, striker biosense quad and boston scientific ultraice.(b)(4).

Manufacturer Narrative

(b)(4).It was reported that an (b)(6) male patient, underwent an atrial fibrillation procedure with a navistar¿ ds electrophysiology catheter and suffered cardiac tamponade which required pericardiocentesis and extended hospitalization.The patient was reported to be in stable condition at the time the complaint was reported.The physician¿s opinion regarding the cause of this adverse event is that he perforated the right ventricle when repositioning the non biosense quad.Brk needle and agilis sheath were used during the procedure.Activated clotting time was greater than 400 seconds.This event is being reported conservatively since we cannot rule out that the bwi catheter may have been involved in the injury.The bwi failure analysis lab received the device for evaluation.The returned device was visually inspected upon receipt and it was found in normal conditions.Per the event, the catheter was tested for electrical performance, temperature response and stockert compatibility and it was found within specifications.Furthermore, a deflection test was performed and the catheter passed.The catheter was also evaluated for carto 3.The catheter was recognized by carto 3 system, no error messages were displayed and the catheter was properly visualized.The force feature was evaluated and passed.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The catheter passed all specifications.The root cause of the tamponade remains unknown.The ifu states that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).

• Brand Name: NAVISTAR¿ DS ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 3259 9; MX 32599
• Manufacturer Contact: shahe garabedian ; 9098397362
• MDR Report Key: 4808606
• MDR Text Key: 5891764
• Report Number: 9673241-2015-00335
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: D-1201-19-S
• Device Catalogue Number: NS7TCF8L174HS
• Device Lot Number: 17196050M
• Other Device ID Number: (01)10846835000603
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2015
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 75