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

Model Number D134805

Device Problems Image Orientation Incorrect (1305); Material Puncture/Hole (1504); Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)

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

Event Date 10/27/2022

Event Type  malfunction  

Manufacturer Narrative

The product investigation was completed.Device evaluation details: visual analysis of the returned sample revealed reddish material in the pebax.The magnetic and force features were tested and no errors were observed.The force values and the vector were observed within specifications.No force issues were observed.Scanning electrode microscope analysis shows evidence of mechanical damage and a hole on the pebax surface.The blood found inside the pebax area may contribute to the force issue.A manufacturing record evaluation was performed for the finished device 30887195l number, and no internal action was found during the review.The issue reported by the customer was confirmed.The instructions for use contain the following information 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 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 ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab identified a hole on the pebax with reddish material inside.The finding was identified on (b)(6) 2022.During the procedure, while coming on ablation the force readings would "shoot up" on the carto 3 system.The force vector started normally and then became inverted and the force readings would increase to 80-90 grams when on ablation.The medical team tried re-zeroing the catheter with no resolution.They replaced the cable with no resolution and then added a second grounding pad with no resolution.Upon removal of the catheter, they discovered a red stain on the tip of the catheter.They confirmed that this was not char.The catheter was replaced and that resolved the issue.Procedure continued.No patient consequences were reported.Force issue is not mdr-reportable.High force is not mdr-reportable.Inverted force vector is not mdr-reportable.Hole in the pebax is 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16000497
• MDR Text Key: 308157156
• Report Number: 2029046-2022-03162
• Device Sequence Number: 1
• Product Code: LPB
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30887195L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2022
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2022
• 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.; THERMOCOOL SMARTTOUCH.