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

Model Number	D134802
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation details: the device evaluation has been completed.The first visual inspection was performed and a dark color was found in the pebax.A second visual inspection was performed and a dark color was found in the pebax sleeve.No internal parts exposed.During further evaluation, a scanning electron microscope (sem) analysis was performed on the pebax area and the results showed evidence of mechanical damage, and a hole on the pebax surface.No other anomalies were observed.A manufacturing record evaluation was performed and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed.The root cause of the damage on the 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.# (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) 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.It was initially reported by the customer that when the case was concluded the physician noticed blood in the spring component.Additional information received indicates they could not tell if there was physical damage to the catheter but confirmed there were no wires exposed.There was no difficulty experienced when maneuvering or withdrawing the catheter from the patient and a 8.5 f agilis medium curl sheath was used.As such, based on the information available, the customer¿s event was assessed as not mdr reportable since the foreign material was found underneath the pebax and there was no damage to the pebax integrity.On 2/26/2020, the complaint product was received for evaluation.Initial visual inspection found a dark color is in the pebax.This was considered to be not reportable.On 3/24/2020, during further product evaluation, a scanning electron microscope (sem) analysis was performed.Sem found showed evidence of mechanical damage and a hole on the pebax surface.These findings were assessed as mdr reportable for the hole in the pebax since the integrity of the device was compromised.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through sem analysis on 3/24/2020 and reassessed this complaint as mdr reportable.

• Brand Name: THERMOCOOL® SMART TOUCH® SF 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: 9968755
• Report Number: 2029046-2020-00549
• Device Sequence Number: 19002345
• Product Code: LPB
• UDI-Device Identifier: 10846835010152
• UDI-Public: 10846835010152
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P030031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/29/2020

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
• Operator of Device: No Information
• Device Expiration Date: 09/19/2020
• Device Model Number: D134802
• Device Catalogue Number: D134802
• Device Lot Number: 30287331M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1