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

Model Number	D-1336-03-S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The investigational analysis has been completed.The returned device was visually inspected and it was found tiny brownish material inside the pebax.The catheter was evaluated for carto 3 system and it was recognized by the system, no error messages were displayed and the catheter was properly visualized.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.The catheter was evaluated for screening test and force calibration check and catheter passed both tests.The force feature was working properly; the force sensor values were found within specifications.However, sem analysis results showed evidence of a hole on the surface of the pebax.It is possible that damage was generated with an unknown object.No other anomalies were observed.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 cannot be confirmed.The root cause of the hole of the surface of the pebax could not be determined.
Event or Problem Description
It was reported that a patient underwent an atrial flutter (afl) procedure with a smart touch unidirectional catheter.A force sensor error (error 106) displayed on the carto 3 system.The cables were replaced with no resolution.The catheter was replaced and the issue resolved.The procedure was completed with no patient consequence.Since the warning functioned as intended, this force sensor error was assessed as not reportable.The biosense webster failure analysis lab received the catheter for evaluation and discovered on may 4, 2017 that the product had tiny brownish material in the pebax.This issue was assessed as not reportable.If material was found underneath the pebax; however, there is no damage to the pebax integrity, then the potential that it could cause or contribute to a death, serious injury, or other significant adverse event was remote.At this time, there was no information to indicate that the there was a break in the integrity of the pebax.During further evaluation on may 19, 2017, the scanning electron microscope (sem) results showed evidence of a hole in the surface of the pebax.Since the catheter integrity had been comprised, this issue has been assessed as a reportable malfunction.The risk to the patient could have been critical due to the potential of thrombus formation from exposure to internal parts of the catheter.The awareness date is reset to may 19, 2017.

• Brand Name: THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• MDR Report Key: 6642610
• Report Number: 9673241-2017-00476
• Device Sequence Number: 707359
• Product Code: LPB
• UDI-Device Identifier: 10846835009019
• UDI-Public: (01)10846835009019(11)170112(17)171231(10)17625760M
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/22/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: D-1336-03-S
• Device Catalogue Number: D133603
• Device Lot Number: 17625760M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2017
• Initial Report FDA Received Date: 06/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1