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); Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 12/9/2020.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an ischemic ventricular tachycardia procedure with a thermocool(r) smart touch" bi-directional navigation catheter and the biosense webster, inc.Product analysis lab observed a hole on the pebax.Initially it was reported that the carto 3 system was displaying a force sensor error 106 when coming on ablation.The cable was replaced without resolution.The catheter was replaced and the issue was resolved.It was reported that the carto 3 system was operating per specifications and was not responsible for the product issue.In addition, it was reported that the catheter had been determined to be the root cause of the complaint reported.The procedure was continued.The force sensor error 106 was assessed as not mdr reportable as the warning functioned as intended.The biosense webster, inc.Product analysis lab received the device for evaluation and observed on (b)(4) 2020 reddish material inside the pebax and a hole on it.The hole on the pebax was assessed as a mdr reportable issue.The awareness date for this finding is 12/15/2020.
Additional Manufacturer Narrative
The device evaluation was completed on 1/13/2021.It was reported that a patient underwent an ischemic ventricular tachycardia procedure with a thermocool® smart touch¿ bi-directional navigation catheter and the carto 3 system was displaying a force sensor error 106 when coming on ablation.The cable was replaced without resolution.The catheter was replaced and the issue was resolved.The device was visually inspected and reddish material was found inside the pebax and a hole.Then, magnetic sensor functionality was tested on the carto and the catheter was properly visualized and no errors were observed.Then, the force sensor feature was tested and it was working properly.The force values were observed within specifications.A manufacturing record evaluation was performed for the finished device 30359421m number, and no internal action was found during the review.The customer complaint regarding force issue was unable to be duplicated during the product investigation.However, the blood inside the pebax area found could be related to the reported issue.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 reference number: (b)(4).

• 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: 11153245
• Report Number: 2029046-2021-00035
• Device Sequence Number: 14438303
• Product Code: LPB
• UDI-Device Identifier: 10846835009194
• UDI-Public: 10846835009194
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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,Followup
• Report Date (Section B): 11/02/2020

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: Health Professional
• Device Expiration Date: 03/01/2021
• Device Model Number: D132704
• Device Catalogue Number: D132704
• Device Lot Number: 30359421M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 01/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM.; THMCL SMRTTCH,BI,NAV,TC,D-F,C3.; UNKNOWN BRAND CABLE.; UNKNOWN BRAND CABLE.; UNKNOWN BRAND CABLE.; UNKNOWN BRAND CATHETER.; UNK_SMARTABLATE GENERATOR.; CARTO 3 SYSTEM; THMCL SMRTTCH,BI,NAV,TC,D-F,C3; UNKNOWN BRAND CABLE; UNKNOWN BRAND CABLE; UNKNOWN BRAND CABLE; UNKNOWN BRAND CATHETER; UNK_SMARTABLATE GENERATOR