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

Model Number	D132704
Medical Device Problem Codes	Material Puncture/Hole (1504); Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation details: the device evaluation has been completed.The returned device was visually inspected and it was found reddish material in the pebax, the pebax was inspected under a microscope and a hole was found on it.Per the event, the catheter was tested for stockert compatibility and it was found within specifications.Then per the reported event, a cool flow pump test was performed and the catheter passed specifications.A manufacturing record evaluation was performed, and no internal action related to the reported complaint condition were identified.The customer complaint was not confirmed.The root cause of the damage on pebax 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# pc-(b)(4).
Event or Problem Description
A patient underwent an ablation procedure with a thermocool® smart touch¿ 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 after the physician removed the thermocool® smart touch¿ bi-directional navigation catheter from the body, it was noticed that there was char on the tip of the catheter.The thermocool® smart touch¿ bi-directional navigation catheter was replaced with a another thermocool® smart touch¿ bi-directional navigation catheter and the issue resolved.The procedure continued.There was no patient consequence.The customer's reported issue of char was assessed as not mdr reportable.Char is a physical phenomenon of radio frequency energy delivery and can be the normal result of the ablation process.The presence of char on the electrodes does not represent a serious injury in itself, nor is it necessarily the result of device malfunction.On 1/29/2021, the bwi product analysis lab received the complaint device for evaluation.On 2/11/2021, the complaint catheter was inspected and it was found with a reddish material inside the pebax.The pebax was inspected under a microscope and a hole was also found in it.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through product analysis on 2/11/2021 and reassessed it as mdr reportable.

• Brand Name: THERMOCOOL SMART TOUCH BI-DIRECTIONAL NAVIGATION CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11467878
• Report Number: 2029046-2021-00355
• Device Sequence Number: 4510771
• Product Code: LPB
• UDI-Device Identifier: 10846835009194
• UDI-Public: 10846835009194
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/11/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/15/2021
• Device Model Number: D132704
• Device Catalogue Number: D132704
• Device Lot Number: 30437999M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1