MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

Device Problems Contamination (1120); High Readings (2459)

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

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation.Bwi conducted a visual inspection and force sensor evaluation of the returned device.Visual analysis of the returned device revealed that there was a hole in the pebax of the thermocool® smart touch® sf bi-directional navigation catheter with a reddish material inside the pebax was also observed.Force sensor testing was performed, in accordance with bwi procedures.The catheter was working correctly, and no force issues could be replicated during the analysis.However, the reddish material inside the pebax could be related to the force issue reported by the customer.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.For product force failure, the instructions for use contain the following information in the carto 3 system manual that should be considered: 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.If the force problem persists, replace the catheter cable or the catheter.On other hand, regarding the additional finding observed, the instruction for use contains the following information: in order to prevent damage to the catheter tip, use the insertion tube supplied with the catheter to advance or retract the catheter through the hemostasis valve of the sheath.Additionally, the customer had also provided pictures of the reported complaint device to aid in the investigation.According to pictures provided, a reddish material was observed on the pebax; no external damage.Customer complaint was confirmed based on the picture received.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

A patient underwent an ablation procedure for paroxysmal atrial fibrilation with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab identified a hole on the pebax.It was initially reported by the customer that when radiofrequency (rf) energy was delivered through the thermocool® smart touch® sf bi-directional navigation catheter, the force rapidly rose from 3 grams to a "high force" displayed on the carto 3 system.The cable was exchanged without resolution.The catheter was exchanged and the errors resolved, the case was continued successfully.Upon inspection of the catheter, there was blood reported "inside the force sensing chamber with the spring." the customer¿s reported issue of ¿high force¿ is not reportable mdr issues since the issue is highly detectable when occurring.The potential that it could cause or contribute to a death, serious injury, or other significant adverse event is low.The customer¿s reported issue of ¿blood inside the force sensing chamber¿ is also not considered to be mdr reportable since there was no indication of external damage or that the integrity of the device had been compromised.As such, the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On (b)(6) 2021, the bwi product analysis lab received the complaint device for evaluation.On (b)(6) 2021, the device was inspected, and it was found with a hole in the pebax with reddish material inside.This finding was assessed as mdr reportable since the integrity of the device was compromised.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through visual analysis on (b)(6) 2021 and reassessed it as mdr reportable.

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12357509
• MDR Text Key: 267850154
• Report Number: 2029046-2021-01376
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30533052M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2021
• Date Manufacturer Received: 07/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2021
• 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
• Treatment: CARTO 3 SYSTEM; THMCL SMTCH SF BID, TC, D-F; UNSPECIFIED CATHETER CABLE