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

Model Number D-1263-07-S

Device Problems Kinked (1339); Difficult to Remove (1528); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/30/2014

Event Type  malfunction  

Event Description

It was reported that during an atrioventricular nodal reentrant tachycardia (avnrt), the catheter was kinked near the proximal electrode.It was stated that the physician was torquing the catheter and noticed a funny bend on the catheter.The catheter was removed with some difficulty through the sheath.There was a kink in the catheter near the proximal electrode.The catheter was replaced and the issue was resolve, the case was completed without any patient consequence.Upon receiving the product in biosense webster lab on october 13 2014, it was noticed that foreign material was found near the tip of the catheter during decontamination, making this event reportable.After follow up with customer regarding this finding, it was stated, this condition was noted upon removal as well as under fluoro.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.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4) it was reported that the catheter was kinked near the proximal electrode.The caller stated that the physician was torquing the catheter and noticed a funny bend on the catheter.The catheter was removed with some difficulty through the sheath.The catheter would deflect but there was a kink in the catheter near the proximal electrode.Catheter was visually inspected upon receipt and tip lumen was found bent.In addition, a foreign material was observed near the tip.A ft-ir test was performed on the foreign material.The representative spectrum obtained showed that the material had a biological composition similar to the one shown by human tissue.However, it remains unknown the origin of it.In addition, the catheter ods were measured and device was 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.All the catheters are inspected for visual damages before packaging.On line inspections are in place to prevent foreign material from leaving the facility.The customer complaint on regards the kink of the catheter has been verified, however it remains unknown the origin of it.For the resistance issue the complaint cannot be confirmed.

• Brand Name: WEBSTER CS CATHETER WITH EZ-STEER TECHNOLOGY AND AUTO ID
• 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 3259 9; MX 32599
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 4216209
• MDR Text Key: 20267015
• Report Number: 9673241-2014-00450
• 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
• Report Date: 09/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: D-1263-07-S
• Device Catalogue Number: BD710DF282CT
• Device Lot Number: 17031272M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2014
• Type of Device Usage: Initial
• Patient Sequence Number: 1