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

Model Number D-1327-01-S

Device Problems Device Packaging Compromised (2916); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2016

Event Type  malfunction  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.The device history record (dhr) has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.(b)(4).The device was not returned to bwi.

Event Description

It was reported that the clean pouch of the smart touch bidirectional catheter was tore and the catheter became dirty when the catheter was taken out from the package.The issue was resolved by changing the catheter to another one.The procedure was completed without patient's consequence.The event is mdr reportable as the inner packaging of the product was compromised.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 6/30/2016.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).

Manufacturer Narrative

(b)(4).It was reported that the clean pouch of the smart touch catheter was torn and that the catheter become dirty when it was taken out of the package.The returned device and pouch were visually inspected and the pouch was found to be torn.Per this condition, scanning electron microscope (sem) testing was performed over the damaged area, and there was evidence of track marks, elongation and delamination on the tyvek induced by an unknown object.During manufacturing process, on line inspections are in place to prevent this type of defect from leaving the facility.A report was run in order to find complaints with the same characteristics in the lot number reported but no other complaints were found.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.Based on available analysis finding results, the failure mode does not appear to be caused by any internal bwi processes.

• Brand Name: THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 5632926
• MDR Text Key: 45374737
• Report Number: 9673241-2016-00309
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: D-1327-01-S
• Device Catalogue Number: D132701
• Device Lot Number: 17390907M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1