MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) LASSO¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Model Number D-1220-39-S

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during an afib - atrial fibrillation procedure, the signals were disappeared when the lasso catheter was connected.The case was completed by changing the catheter without any patient's consequence.Multiple attempts were done to request for further details of the event.However no additional information has been provided.Since it is unknown that noise occurred on all the channels, including the 12 leads of bs ecgs and all ic (intracardiac) on both carto and ep recording systems and also it is unknown that any ecg/ekg signal was available for the physician to monitor the patient's heart rhythm, bwi takes conservative approach and reports this event.

Manufacturer Narrative

(b)(4).It was reported that during an afib - atrial fibrillation procedure, the signals were disappeared when the lasso catheter was connected.The case was completed by changing the catheter without any patient¿s consequence.Multiple attempts were done to request for further details of the event.However no additional information has been provided.Since it is unknown that noise occurred on all the channels, including the 12 leads of bs ecgs and all ic (intracardiac) on both carto and ep recording systems and also it is unknown that any ecg/ekg signal was available for the physician to monitor the patient¿s heart rhythm, bwi takes conservative approach and reports this event.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 and it was found within specifications.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 customer complaint cannot be confirmed.

• Brand Name: LASSO¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• 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 ; 9497893837
• MDR Report Key: 5114066
• MDR Text Key: 27465935
• Report Number: 9673241-2015-00691
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K002333
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: D-1220-39-S
• Device Catalogue Number: D7L1020RT
• Device Lot Number: 17186617L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2015
• 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