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 Bent (1059); Hole In Material (1293); Unable to Obtain Readings (1516); Physical Property Issue (3008); Scratched Material (3020)

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

Event Date 11/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Upon receipt, the returned device was visually inspected, and the helix spring was found slightly bent, causing damage to the pebax.Additionally, some broken wires were observed inside near the helix spring.Per this condition, scanning electron microscope (sem) analysis was performed over the pebax area of catheter, and evidence of scratches/pinholes was discovered.It is possible that an unknown object hit and ruptured the pebax.Per the reported event, the catheter was evaluated for electrical resistance and thermocouple comportment.The thermocouple test failed; no readings were observed in the 1st or 2nd electrodes.Further examination revealed that the thermocouple and electrode wires were broken near the tip area.This could be a result of the bent helix spring.During the manufacturing process, all catheters are inspected for visual damage before packaging.On-line inspections are in place to prevent catheters with this type of damage from leaving the facility.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.Regarding the pebax damage, based on available analysis results, it cannot be identified whether the issue is related to an internal or an external cause.

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool smart touch unidirectional catheter where the temperature would not display.The catheter was replaced with another, and the procedure continued without any report of patient consequence.On 1/10/2017, the biosense webster failure analysis lab received the device, and the tip was found to be bent near the helix spring, causing damage to the sensor sleeve.The sleeve was not found to be peeling, though a bit of excessive polyurethane was noted.Since the catheter integrity had not been found to be compromised and no internal parts were exposed, the risk to the patient was low, and the event was not considered mdr reportable.However, on 2/17/2017, the biosense webster failure analysis lab performed scanning electron microscope analysis on the device, and evidence of scratches/pinholes was discovered.Exposure to the internal catheter components creates a critical risk of thrombus to the patient.As a result, this event is mdr reportable.

• 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: 6413901
• MDR Text Key: 70540537
• Report Number: 9673241-2017-00214
• 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
• Report Date: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: D-1336-04IL-S
• Device Catalogue Number: D133604IL
• Device Lot Number: 17519604M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2016
• 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