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

Model Number D132705

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2020

Event Type  malfunction  

Manufacturer Narrative

The biosense webster product analysis lab received the device for evaluation.Upon initial inspection, reddish brown material was observed on the distal tip.The observed reddish brown material has been assessed as not mdr reportable.Further testing was then performed.The investigational analysis completed 4/17/2020.The device was visually inspected.Reddish brown material and a cut on the surface of pebax sleeve with internal parts exposed, was observed.The catheter was connected to carto.The catheter was properly visualized, and no errors were observed.The force sensor feature was tested, and it was found to be working properly.The force values were observed within specifications.A manufacturing record evaluation was performed, and no internal actions were reported were identified.The customer complaint cannot be 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.Manufacture reference no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found a cut on the surface of the pebax sleeve.Initially it was reported that at bout 3 hours after use, high force without metal interference was observed.Re-zeroing was conducted but zero could not be obtained.The issue was resolved by changing the smart touch catheter to another one.No adverse patient consequences were reported.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On 4/17/2020, the bwi pal found a cut on the surface of the pebax sleeve leaving internal parts exposed.The observed cut has been assessed as an mdr reportable malfunction as device integrity was compromised.The awareness date has been reset to 4/17/2020.

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10064397
• MDR Text Key: 202031766
• Report Number: 2029046-2020-00609
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2020
• Device Model Number: D132705
• Device Catalogue Number: D132705
• Device Lot Number: 30255613M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2020
• Date Manufacturer Received: 04/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1