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

Catalog Number D134805

Device Problem Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2019

Event Type  malfunction  

Manufacturer Narrative

The biosense webster inc.Product analysis lab received the device for evaluation.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.A manufacturing record evaluation was performed for the finished device and no internal actions were found during the review.Manufacture reference no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation (stsf) catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found the distal tip cracked with half missing.Initially, it was reported that mid procedure, a high force reading displayed.Catheter was re-zeroed.However, the force reading was still high in the blood pool.The cable was replaced.The stsf catheter was disconnected and the high force issue persisted.Force sensor error 106 then displayed.Re-zeroing was attempted several times with no resolution.Catheter replacement resolved the issue.The procedure was then completed, and no adverse patient consequences were reported.The observed high force and force sensor error 106 issues have been assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On (b)(6) 2019, the bwi pal received the device for evaluation.Upon initial inspection, the distal tip was observed cracked with half missing.These findings have been assessed as an mdr reportable malfunction as the device integrity was compromised.The awareness date has been reset to (b)(6) 2019.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation (stsf) catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found the distal tip cracked with half missing.Initially, it was reported that mid procedure, a high force reading displayed.Force sensor error 106 then displayed.Additional information was received on (b)(6)2019 , indicting the cracked distal tip with half missing observed the bwi pal, was not noticed during the procedure or after replacement.The procure was complicated with no patient consequences no adverse event reported.The investigational analysis completed (b)(6)2019.The returned device was inspected and the distal was found cracked with half missing.The functional test was unable to be performed, due to the returned condition of the device.A manufacturing record evaluation was performed and no internal actions were identified.The customer complaint cannot be confirmed.The root cause of the damage observed 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 shipment since the customer clarified that the damage was not observed during the procedure or the replacement of the device.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: pc-000502730.

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 8891052
• MDR Text Key: 154268339
• Report Number: 2029046-2019-03543
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2020
• Device Catalogue Number: D134805
• Device Lot Number: 30206699L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Date Manufacturer Received: 08/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1