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

Catalog Number D133604IL

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).The product investigation was completed.Device evaluation details: the device was visually inspected, and the pebax was found damaged (hole) with foreign material inside.Then, magnetic sensor functionality was tested on carto and the catheter was properly visualized and no errors were observed.Then, the force sensor feature was tested, and it was working properly, the force values were observed within specifications.A manufacturing record evaluation was performed and no internal action related to the reported complaint were identified.The customer complaint regarding force issue could not be duplicated during the product investigation.However, it was determined that the foreign material inside the pebax area could be related to the reported issue.The root cause of the pebax damage cannot be related to the manufacturing process as there is evidence that the device was manufactured in accordance with documented specification and procedures.The damage could be related to the handling of the device during the procedure, however, this cannot be conclusively determined.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

A patient underwent an atrial flutter (afl) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter for which biosense webster¿s product analysis lab identified a hole in the pebax with foreign material inside.During the procedure, no force values were being displayed.A second catheter was used to complete the operation.There was no report of an adverse event for the patient.The force issue during the procedure is not mdr reportable.However, the hole in the pebax with foreign material inside is mdr 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: 10583729
• MDR Text Key: 209614164
• Report Number: 2029046-2020-01322
• Device Sequence Number: 1
• Product Code: LYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 08/28/2020

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: 12/11/2021
• Device Catalogue Number: D133604IL
• Device Lot Number: 30307857M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Initial Date Manufacturer Received: 08/28/2020
• Initial Date FDA Received: 09/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2020
• 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