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 Bent (1059); Loose or Intermittent Connection (1371); Material Integrity Problem (2978)

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

Event Date 10/21/2015

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 supraventricular tachycardia (svt) procedure with a smart touch bidirectional catheter and the biosense webster failure analysis discovered that the returned catheter had the integrity of the pebax compromised.Initially, it was reported that the cable was not able to be inserted into the catheter because there was a loose pin.The catheter was replaced.The procedure was completed with no patient consequence.The issue with the connector pins, was assessed as not reportable.The device can not be used.The most likely consequence was an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The biosense webster failure analysis discovered the returned catheter condition on november 11, 2015.The sensor sleeve (pebax) had been cut and the inside sleeve had off white material.The connector had one pin bent down and touching another pin.Second pin was bent slightly touching another pin and two slightly bent pins.Per the returned catheter condition of the pebax cut and inside the sleeve it had off white material, the integrity of the pebax has been compromised.Therefore, this issue has been assessed as a reportable malfunction.The awareness date has been reset to november 11, 2015.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent a supraventricular tachycardia (svt) procedure with a smart touch bidirectional catheter.The cable was not able to be inserted into the catheter because there was a loose pin.The catheter was replaced.The procedure was completed with no patient consequence.The returned device was visually inspected upon receipt and a cut with white material was observed at the sensor sleeve (pebax).Per this condition 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 scratches and a pinhole induced by an unknown object.An internal corrective action has been opened to investigate this type of pebax damage.Continuing with the visual inspection, the connector pins were found bent.No further test could be performed but it can be concluded that the bent pins were the cause of the connection issue.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.All the catheters are inspected for visual damages before packaging.On line inspections are in place to prevent this type of damage/defect from leaving the facility.The customer complaint has been verified.However the root cause remains unknown.An internal corrective action has been opened to investigate this type of pebax damage.

• 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 ; 9497893837
• MDR Report Key: 5287121
• MDR Text Key: 33850995
• Report Number: 9673241-2015-00903
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/21/2015

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: 10/31/2015
• Device Model Number: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: 17120249M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/21/2015
• Initial Date FDA Received: 12/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2014
• 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