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

Model Number D134805

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2019

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.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found cracked peek housing, exposing internal parts.Initially, it was reported that during the procedure there was a problem with the catheter manipulation.The curve would not bend properly.Catheter replacement resolved the issue.No adverse patient consequences were reported.The observed inadequate curved has 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 12/19/2019, the bwi pal received the device for evaluation and found the eek housing cracked, exposing internal parts.The observed cracked peek housing has been assessed as an mdr reportable malfunction, as device integrity was compromised.The awareness date has been reset to 12/19/2019.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found cracked peek housing, exposing internal parts.Initially, it was reported that during the procedure there was a problem with the catheter manipulation.The curve would not bend properly.The investigational analysis completed 1/20/2020.The device was visually inspected and reddish-brown material was found in the shaft near the distal tip.During the second visual the reddish-brown material was confirmed and the peek housing was found cracked, with internals parts exposed.Deflection testing was performed and the catheter failed.A failure analysis was performed and the catheter was dissected on the tip area, the t bar was found slid down causing the improper deflection condition.A manufacturing record evaluation was performed and no internal actions were identified.The customer complaint was confirmed.The root cause of peek housing cracked is related with the t-bar slid sown from the anchor place.The root cause of the catheter t-bar displacement cannot be determined since there was evidence of the properly assembly of the device.Manufacture reference no: (b)(4).

Manufacturer Narrative

During an internal review on 5/5/2020, it was noticed that the manufacture date and expiration date were omitted in error.Section d4 expiration date has been updated with 6/17/2020 and section h4 manufacture date has been updated with 6/18/2019.Manufacture reference no: (b)(4).

• 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: 9579579
• MDR Text Key: 200072513
• Report Number: 2029046-2020-00065
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/27/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2020
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30240263L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Initial Date Manufacturer Received: 12/20/2019
• Initial Date FDA Received: 01/12/2020
• Supplement Dates Manufacturer Received: 01/20/2020; 05/05/2020
• Supplement Dates FDA Received: 02/18/2020; 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1