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

Catalog Number D133604IL

Device Problems Material Separation (1562); Sharp Edges (4013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/25/2019

Event Type  malfunction  

Manufacturer Narrative

The bwi pal received a video for analysis.According to video provided by customer, the high force value initially reported was observed on carto 3 screen.The observed force issue has been assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The product investigational analysis completed 2/20/2020.The returned device was visually inspected and it was found that the dome of the pebax had a dent and reddish material inside the pebax sleeve.During a second closer visual inspection, the dented pebax dome and reddish material in pebax sleeve was confirmed.No internal parts were exposed.The magnetic and force features were tested and no issues were observed.Scanning electron microscope (sem) testing was performed on the pebax area and the results showed show mechanical damage of electrode and the polyurethane (pu) border.The electrode edge was observed without a pu border.Additionally, separation was observed between the pu border on the pebax and the electrode border.A manufacturing record evaluation was performed, and no internal actions were identified.The customer complaint regarding force issue was not confirmed since during the product analysis the issue was unable to duplicated however, the blood found inside the tip could be related to the force issue reported.The root cause of the damage on pebax and electrode 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.Manufacture reference no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a thermocool® smart touch¿ electrophysiology catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found a damaged electrode and separation exposing internal parts.Initially, it was reported that during the procedure a force sensor error was displayed.A second catheter was used to complete the operation.No adverse patient consequences were reported.The observed force issue has been assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On 2/13/2020, scanning electron microscope testing was performed was performed on the pebax area and the results showed mechanical damage of the electrode and the polyurethane (pu) border.The electrode edge was observed without a pu border.Additionally, separation was observed between the pu border on the pebax and the ring border the observed damaged electrode with sharp edges and separation exposing internal parts has been assessed as an mdr reportable malfunction.The awareness date has been reset to 2/13/2020.

• 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 ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9819994
• MDR Text Key: 196221080
• Report Number: 2029046-2020-00381
• 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: 01/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: D133604IL
• Device Lot Number: 30247919M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Date Manufacturer Received: 02/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2019
• 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