MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) WEBSTER CS CATHETER WITH EZ-STEER TECHNOLOGY; ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

Model Number D-1263-05-S

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 01/26/2017

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation.The product was received in its original sealed package.However, the product was not returned in its original box.During the first visual inspection, the bwi failure analysis lab did not find any foreign material on the catheter or on the package.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).

Event Description

It was reported that a patient underwent a procedure with an ez steer coronary sinus catheter.Prior to use in the procedure, foreign material was noted inside the ez steer catheter¿s packaging.It was described as a black spec around the handle portion of the packaging.This event is being conservatively assessed as a reportable malfunction as if the foreign material had not been noticed prior to the procedure, it could have been introduced into the sterile field.

Manufacturer Narrative

During additional assessment of the returned product on march 7, 2017, the biosense webster, inc.Failure analysis lab found a rupture in the distal of the pouch and foreign material inside the package.The foreign material was initially reported and assessed as a reportable malfunction.The new finding of the rupture in the pouch is also being assessed as a reportable malfunction.A packaging defect that compromises the sterility of the product exposing patients to the possibility of the introduction of microorganisms into the vasculature, leading to an infectious process, bacteremia or sepsis.This may result in the need for additional medical intervention or potentially may lead to permanent injury or impairment.(b)(4).

Manufacturer Narrative

(b)(4).It was reported that a patient underwent a procedure with an ez steer coronary sinus catheter.Prior to use in the procedure, foreign material was noted inside the ez steer catheter¿s packaging.It was described as a black spec around the handle portion of the packaging.The returned device was visually inspected and a rupture was found in the distal side of the pouch and foreign material inside the package.Per the rupture condition, a scanning electron microscope (sem) testing was performed and results show the pouch external surface presented evidence of track marks, elongations and perforation on the tyvek.It is possible that the rupture on the tyvek were causes from the inside to the outside due to the damaged conditions found during the analysis.Per the foreign material found, a fourier transform infrared spectroscopy (ft-ir) was performed in order to identify the type of foreign material.The results demonstrated that the material is primarily composed of a polyamide-based material, plastics commercially known as nylons.The comparison test conducted as part of this investigation revealed that biosense webster, inc.Component rocker arm has a rather similar ir spectrum, hence aforementioned component should be pinpointed as a potential source of origin in case it is utilized during the manufacturing process of the device.Due to the ft-ir results, a meeting with the manufacturing team was performed to be aware of this issue and to investigate the root cause of the loop condition.During the investigation, it was concluded that this issue is related with the assembly process of the catheter leaving particles on the catheter which potentially have come loose during the transportation of the catheter.Additionally, an awareness session was provided to the production associates to be aware of this kind of issue.A search of similar complaints with this kind of issue was performed and no others complaints were found, this appears to be an isolated case.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 has been verified.The root cause of the rupture on the pouch could be caused during shipment or return of the product due to friction of the tray by vibrations.Regarding the foreign material found, it could become loose during the transportation of the catheter.However, this appears to be an isolated case.

• Brand Name: WEBSTER CS CATHETER WITH EZ-STEER TECHNOLOGY
• Type of Device: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• 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: 6331653
• MDR Text Key: 67853722
• Report Number: 9673241-2017-00120
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090898
• 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: 01/26/2017

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: 08/31/2019
• Device Model Number: D-1263-05-S
• Device Catalogue Number: BD710DF282RTS
• Device Lot Number: 17570692M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2017
• Initial Date FDA Received: 02/15/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/16/2017; 05/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2016
• 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