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

Catalog Number D133604IL

Device Problems Image Orientation Incorrect (1305); Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

The device evaluation was completed on 08-jul-2021.The product was returned to biosense webster for evaluation.Visual inspection and functional testing were conducted on the returned device.The visual analysis of the returned sample revealed that the thmcl smarttouch catheter was received with reddish material inside the pebax, a microscopic inspection revealed that the pebax has a hole on it.The device was tested for functionality with a generator and a carto 3 patient interface unit system, the shaft proximity interference (spi) screening test was performed and there are no errors for the device and the catheter passed the test.Based on these results, the customer complaint was confirmed, since the damage and the blood noted on the pebax could be related with the customer complaint; however, this cannot conclusively determine.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.As part of the biosense webster quality process, all devices are manufactured, inspected, and released to approved specifications.The inverted vector was not duplicated during the analysis; the instructions for use do contain the following actions: to ensure accurate force readings, verify that the force reading is near zero when the catheter is not in contact with tissue.If the force reading is not near zero when the catheter is not in contact with tissue, perform zeroing.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿force vector inverted¿.Investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: membrane ((b)(4)) were selected as related to the biosense webster, inc.Product analysis lab finding of the ¿hole on the pebax with reddish material inside of it.¿ manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch¿ electrophysiology catheter and the biosense webster, inc.Product analysis lab observed a hole on the pebax.Initially, during the procedure, the force vector displayed on the carto 3 system was inverted.A second catheter was used to complete the procedure.There was no patient consequence reported.The displayed inverted force vector was assessed as not mdr reportable.Despite the incorrect force vector visualization, the device can function as intended, because the catheter can still be displayed using fluoroscopy and the carto 3 navigation system.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The risk to the patient was low.The biosense webster, inc.Product analysis lab received the device for evaluation and observed on 08-jul-2021 reddish material in the pebax.The pebax was inspected under a microscope and a hole was found on it.The hole on the pebax was assessed as a mdr reportable malfunction.The awareness date for this bwi product analysis lab finding is 08-jul-2021.

• Brand Name: THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12268676
• MDR Text Key: 264958917
• Report Number: 2029046-2021-01238
• 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: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2022
• Device Catalogue Number: D133604IL
• Device Lot Number: 30494527M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Date Manufacturer Received: 07/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2021
• 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