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

Model Number D-1327-05-S

Device Problems Flushing Problem (1252); Material Integrity Problem (2978)

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

Event Date 02/25/2016

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 atrial fibrillation procedure with a thermocool® smarttouch® bi-directional navigation catheter and inadequate irrigation occurred.The saline did not come out from one of the irrigation holes of the smart touch catheter when flushed.The issue was resolved by changing the catheter to another one.The procedure was completed without patient consequence.This event was originally assessed as not mdr reportable because the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The device was returned to the biosense webster failure analysis lab and during visual inspection it was discovered that the sensor sleeve has one open cut allowing the reddish brown material inside about 1mm from the proximal side of electrode #2.Also, there was one surface scratch on sleeve.Additional information was received on the returned catheter condition.There was no difficulty removing the catheter through the sheath that may have caused this damage.The damage was not noticed prior to sending the catheter back for analysis.The returned catheter condition finding has been assessed as mdr reportable because the integrity of the catheter has been compromised which poses a potential risk to the patient.The awareness date for this record is april 20, 2016 because that is when the reportable damage was discovered.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a thermocool® smarttouch® bi-directional navigation catheter and inadequate irrigation occurred as one of the holes was not irrigating.The returned device was visually inspected and it was found that sensor sleeve (pebax) had a cut allowing reddish brown material inside, which is why this complaint was reported to the fda.A scanning electron microscope (sem) testing was performed over the damaged area of catheter and it was found that the pebax external surface presented evidence of scratching and a rupture induced by an unknown object.Then per the reported event, an irrigation test was performed and the catheter passed.All irrigation holes were properly irrigating, no occluded holes 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.

• 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: 5651284
• MDR Text Key: 46265465
• Report Number: 9673241-2016-00328
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2016
• Device Model Number: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: 17198997M
• Other Device ID Number: SEE SECTION H10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/24/2016
• Initial Date FDA Received: 05/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2015
• 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