MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D-1336-02-S

Device Problems Break (1069); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2016

Event Type  malfunction  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.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.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.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a thermocool smarttouch uni-directional navigation catheter and foreign material was present on the tip.After mapping in the right and left atrium with no radiofrequency applied, the catheter had damaged polyurethane/housing on the tip.This was noted after use in the patient.The case was completed with cryo and there was no patient harm.Upon request, additional information was received on the event.There were no wires exposed, no sharp rings or any resistance or difficulty during insertion or removal of the catheter.The catheter was not pre-shaped and a cryo medtronic sheath was used.An object was noticed to be hanging off of the distal tip.The material was tissue color white and was maybe smaller than 1mm with an unknown shape.This event is mdr reportable because the presence of foreign material within the usable length of the catheter has the potential to pose a risk to the patient.The damage noted will need further reportability assessment once the catheter has been returned.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 03/25/2016.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's ref.No: (b)(4).

Manufacturer Narrative

This event has been reassessed as not mdr reportable because the foreign material discovered on the catheter was a biological composition similar to human tissue, this does not pose any risk to the patient.In addition, no damage was discovered on the catheter tip.(b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a thermocool® smarttouch® uni-directional navigation catheter and foreign material was present on the tip.After mapping in the right and left atrium with no radiofrequency applied, the catheter had damaged polyurethane/housing on the tip.This was noted after use in the patient.Upon receipt, the catheter was visually inspected and it was found in normal conditions.Catheter tip was inspected and no damage was observed at the peek housing or pebax area.However, during the visual inspection foreign material was found on ring #1.A fourier transform infrared spectroscopy analysis was performed and it was found that the material has biological composition similar to human tissue.Catheter outer diameters were measured 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 regarding damage on the catheter tip cannot be confirmed.

• Brand Name: THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 5518754
• MDR Text Key: 41184870
• Report Number: 9673241-2016-00208
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• 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: 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: D-1336-02-S
• Device Catalogue Number: D133602
• Device Lot Number: 17268116M
• Other Device ID Number: SEE H10.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2015
• 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