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 Disconnection (1171); Hole In Material (1293); Device Contamination with Chemical or Other Material (2944)

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

Event Date 06/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The returned device was visually inspected and reddish material was found inside the catheter tip.For the condition observed, a scanning electron microscope (sem) test was performed and the results showed evidence of a hole on the surface of the pebax.It is possible that the damage was generated with an unknown object.No other anomalies were observed.Then per the reported event, 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.During manufacturing process, all the catheters are inspected for visual damages before packaging.On line inspections and functional tests are in place to prevent this type of damage from leaving the facility.The customer complaint cannot be confirmed.The root cause of damage cannot be determined.

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a thermocool® smarttouch® bi-directional navigation catheter and a deflection issue occurred.The catheter would not curve by pushing and pulling the thumb knob.It was thought the issue may have been caused by puller wire disconnection.The catheter was replaced and the issue resolved.The procedure was completed with no patient consequence.This event was assessed as not mdr reportable because the potential that it could cause or contribute to a death, serious injury, or other significant adverse event is remote.On august 4, 2017, the device was returned to the biosense webster inc failure analysis lab and during visual inspection it was discovered that there was reddish looking material inside the pebax of the catheter.This finding was assessed as not mdr reportable because if foreign material is observed inside the pebax which does not belong to the catheter, however; there¿s no exposure of internal components, or any evidence that the integrity of the catheter has been compromised, the potential that it could cause or contribute to a death, serious injury, or other significant adverse event is remote.After further investigation, on august 24, 2017, scanning electron microscope (sem) results showed evidence of a hole and stress marks on the surface of the pebax.This finding is mdr reportable because the risk to the patient could have been critical due to the potential of thrombus formation from exposure to internal parts of the catheter.The awareness date has been reset to august 24, 2017, the day the reportable finding was discovered.

• 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: 6856471
• MDR Text Key: 86008192
• Report Number: 9673241-2017-00676
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: (01)10846835009200(11)170125(17)171231(10)17631363M
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Report Date: 06/02/2017

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: 12/31/2017
• Device Model Number: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: 17631363M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2017
• Initial Date FDA Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2017
• 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