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

Model Number D-1201-15-S

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)

Event Date 05/31/2017

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Since the lot number is unknown, the full udi number can not be provided.Concomitant product: soundstar eco catheter, model #: unknown, lot #: unknown.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a female patient underwent a voltage mapping procedure with multiple biopsy sites in the right and left ventricles with a navistar ds catheter and suffered a cardiac tamponade requiring pericardiocentesis.At the end of the procedure, the intracardiac echocardiogram (ice) was negative for an effusion.Post-procedure, while in the recovery room, the patient became hypotensive.Systolic blood pressure decreased from 90mmhg to 70mmhg.Tamponade was confirmed via bedside echocardiogram.Pericardiocentesis yielded an unspecified amount of fluid.Patient was reported to be in stable condition.There is no information regarding extended hospitalization.Patient outcome was improved.There were no factors cited that may have contributed to the adverse event.Physician indicated that although it is unknown when the injury occurred, it was likely during biopsy.Physician¿s opinion regarding the cause of the adverse event is that it was related to biopsy sampling.No transseptal puncture was performed.There is no sheath information.Generator parameters, generator settings, power titration, overall ablation time at the site of injury, and last ablation cycle time at the site of injury were not reported, as no ablation was performed.Patient received anticoagulant during the procedure with activated clotting time maintained in an unspecified range.There were no errors reported on any bwi equipment during the procedure.Since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.

• Brand Name: NAVISTAR DS
• 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 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6671785
• MDR Text Key: 78546871
• Report Number: 9673241-2017-00516
• 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
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-1201-15-S
• Device Catalogue Number: NS7TCB8L174HS
• Device Lot Number: UNKNOWN_D-1201-15-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2017
• 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