MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Model Number D-1336-04IL-S

Device Problems Material Integrity Problem (2978); Positioning Problem (3009); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2015

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation.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 a thermocool smarttouch uni-directional navigation catheter and a magnetic sensor error occurred and the catheter could not curve to specification.The catheter was changed to another to complete the procedure.There was no patient consequence.This event was originally assessed as not reportable as the potential risk that the issues could cause or contribute to a serious injury or death is remote.The biosense webster failure analysis lab received the device for evaluation on september 16, 2015.During visual inspection it was discovered that the catheter had rough rings, a lead wire exposed and pebax damage.Upon request additional information was received on the returned catheter condition.There was no difficulty withdrawing the catheter.This condition was not noticed prior to use, upon withdrawal or prior to sending the catheter back for analysis.All of the findings discovered by the lab are indicative of reportable events due to the potential risk to the patient from the loss of catheter integrity as well as exposed and rough metal components.The awareness date for this record is september 16, 2015 because that is when the damage was discovered.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent a procedure with a thermocool® smarttouch® uni-directional navigation catheter and a magnetic sensor error occurred and the catheter could not curve to specification.The returned device was visually inspected upon receipt and peek housing was found slightly bent with rough gaps and lead wire exposed which is why this complaint was reported to the fda.Per this condition a scanning electron microscope (sem) analysis was carried out and it was found that the peek housing presents a plastic deformation that can suggest the application of the stress that exceeds the material yield strength.Polyurethane (pu) material was found due to the peek housing flexion.Continuing with the visual inspection, sensor sleeve (pebax) has off-white and black material inside it and appears to be damaged.Sem analysis was performed to the area and the results show that the separation section presented evidence of scratches and displacement material between the pu and pebax.It is possible that an unknown object hit the pebax and pu causing the cracking.An internal corrective action was created to address the pebax issues on smart touch catheters.Further information received indicates that the visual conditions were not noticed during the procedure or prior to sending the catheter back.Catheter damages might happen while returning the catheter back to bwi.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.Per the complaint reported the catheter was tested and it passed eeprom test, but failed carto 3 test due to a spinning icon was detected during mapping.Further examination showed that the sensor was within specifications.Therefore, the root cause of the spinning icon remains unknown.Then a deflection test was performed and the catheter passed.The customer complaint regarding a magnetic issue has been verified.The root cause of the spinning icon could not be determinate.

• Brand Name: THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• 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: 5131494
• MDR Text Key: 28075490
• Report Number: 9673241-2015-00707
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 08/29/2015

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: 03/31/2016
• Device Model Number: D-1336-04IL-S
• Device Catalogue Number: D133604IL
• Device Lot Number: 17226455M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2015
• 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