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

Model Number D-1336-05IL-S

Device Problems Bent (1059); Hole In Material (1293); Failure to Calibrate (2440); Material Protrusion/Extrusion (2979); Physical Property Issue (3008)

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

Event Date 10/24/2016

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 an ablation procedure with a thermocool smarttouch uni-directional navigation catheter and a force issue occurred as the force sensor could not be calibrated.The catheter was changed and the procedure was completed with no patient consequence.This event was assessed as not mdr reportable because potential that it could cause or contribute to a death, serious injury, or other significant adverse event is low.On (b)(6) 2016, the biosense webster failure analysis lab discovered the tip section is bent on the proximal side of the polyurethane margin causing the helix spring to be damaged.The clear sensor sleeve is damaged with holes and metal exposed.The peek housing is bent on proximal side of ring #3.There was no reported difficulty that may have caused this damage.The returned catheter condition was not noticed prior to use of the catheter, upon withdrawal or prior to sending the catheter for analysis.This finding is mdr reportable because if internal catheter parts are exposed, then the risk to the patient is critical due to the potential for thrombus formation.The other findings are not mdr reportable because there was no break to catheter integrity or exposed parts in those areas.The awareness date was reset to (b)(6) 2016, the date the reportable lab finding was discovered.

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).It was reported that a patient underwent an ablation procedure with a thermocool® smarttouch® uni-directional navigation catheter and a force issue occurred as the force sensor could not be calibrated.The returned device was visually inspected upon receipt and the peek housing was found bent on proximal side.The helix spring was found damaged causing damages in the pebax, a hole and metal exposed were observed, which is why this complaint was reported to the fda.Per this condition, a scanning electron microscope (sem) testing was performed over the pebax area of catheter and the results showed that the external surface of the pebax exhibit evidence of pinhole and scratches condition.It is possible that unknown objects hit and ruptured the pebax.The external surface of the peek housing exhibited evidence of a bent condition, cracking between the polyurethane and peek housing, however no perforation was observed.It is possible that an unknown object causes the bent condition.Per the event, the catheter was evaluated for eeprom, and the functionality of the sensor catheter was tested on the carto 3 system.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.The catheter was recognized by the carto 3 system; however error 106 (force sensor error) was displayed.The catheter was then dissected and it was determined that the root cause was an internal failure of the sensor.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 has been verified.The root cause of internal damage at the sensor could not be determined.Regarding the pebax and peek housing damages found, based on available analysis results; it cannot be identified whether the issue is related to an internal or an external cause.

• 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 ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6215650
• MDR Text Key: 63871198
• Report Number: 9673241-2016-00932
• 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: Initial,Followup
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• 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-1336-05IL-S
• Device Catalogue Number: D133605IL
• Device Lot Number: 17489590M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2016
• 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