MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D133604IL

Device Problems Material Puncture/Hole (1504); Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the device investigation has been completed.The device was visually inspected and a reddish material was found inside the clear pebax.Then, magnetic sensor functionality was tested on carto and the catheter was properly visualized and no errors were observed.The force sensor feature was tested and it was working properly¿ the force values were observed within specifications.The pebax was sent for sem analysis and it showed evidence of mechanical damage and a hole on the pebax surface.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint cannot be confirmed.The root cause of the damage on pebax cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the handling of the device during the procedure, however, this cannot be conclusively determined.Additionally, photographs provided by customer however no results can be obtained.The customer¿s complaint is not confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(6).(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter for which biosense webster¿s product analysis lab has identified a hole on the pebax.It was initially reported by the customer that during the operation, the force values displayed were high and the pressure value was not stable.A second catheter was used to complete the operation.There were no patient consequences reported.The customer¿s reported high force issues (high reading and inaccurate readings) are not mdr reportable since the potential risk that it could cause or contribute to a serious injury or death is remote.On 11/15/2019, the biosense webster inc.(bwi) product analysis lab received the device for evaluation.During initial visual inspection, a reddish-brown material was observed inside the pebax sleep.This finding was reviewed and assessed as not reportable since the integrity of the device was maintained.On 12/6/2019, the catheter was further analyzed and subjected to a scanning electron microscope (sem) analysis on 12/6/2019 and found evidence of mechanical damage and a hole on the pebax surface.Object that cause the damage is unknown.No other anomalies were observed.This finding was assessed as mdr reportable for the hole in the pebax.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through sem analysis on 12/6/2019 and has reassessed this complaint as reportable.

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9548290
• MDR Text Key: 196237725
• Report Number: 2029046-2020-00005
• 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
• Report Date: 11/04/2019

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: 05/19/2020
• Device Catalogue Number: D133604IL
• Device Lot Number: 30226311M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 01/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1