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 Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2016

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 a procedure with a smart touch unidirectional catheter.Initially, it was reported that during the procedure, the catheter could not curve to the specification.The catheter was changed and the procedure was completed with no patient consequence.This issue was assessed as not reportable as the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The catheter was received at the biosense webster failure analysis lab on (b)(6) 2016.During the first visual inspection it was noticed that the helix spring was bent inside the pebax sleeve.Also bent was the peek housing on the proximal side of ring #3.There were no sharp edges or exposed parts.Both these findings were assessed as not reportable as the helix spring was bent, but remained internalized within the pebax sleeve.The peek housing bend did not create any sharp edges and the integrity was maintained.During further analysis of the catheter, it was discovered on (b)(6) 2016 that the pebax appeared to have damage/hole.On (b)(6) 2016 a scanning electron microscope (sem) was performed and the results show that the external surface of the pebax exhibited evidence of scratching and a pinhole.The pinhole has been assessed as a reportable malfunction as the integrity has not been maintained.Therefore, the awareness date of this reportable issue is (b)(6) 2016.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent a procedure with a smart touch unidirectional catheter.Initially, it was reported that during the procedure, the catheter could not curve to the specification.The catheter was changed and the procedure was completed with no patient consequence.The returned device was visually inspected and helix spring was found bent inside pebax as well as peek housing.During a second visual inspection during the analysis a hole was observed at the pebax area.A scanning electron microscope (sem) test was performed and results indicate that the external surface of the pebax exhibited evidence of scratching and a pinhole induced by an unknown object.Further information received indicates that no resistance was noticed during the procedure and that catheter condition was not noticed prior to sending the catheter back for analysis to biosense webster, inc.A deflection test was performed and the catheter passed.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 a deflection issue cannot be confirmed.The root cause of the pebax damage observed cannot be determined.Based on available analysis results, it could not 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: 5845615
• MDR Text Key: 52407948
• Report Number: 9673241-2016-00479
• 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: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: D-1336-05IL-S
• Device Catalogue Number: D133605IL
• Device Lot Number: 17327119M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2015
• 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