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 05/18/2020

Event Type  malfunction  

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation.Device evaluation summary was completed on july 1, 2020: the device was visually inspected and it was found with reddish material in the pebax sleeve.No internal parts exposed.A second closer inspection was performed and revealed reddish material and a cut on the surface of the pebax sleeve.Internal parts exposed were observed.Then, magnetic sensor functionality was tested on carto and the catheter failed, error 106 was observed.A failure analysis was performed and the catheter was dissected on the tip area.Loss of electrical continuity at the sensor was found.It was determined that the root cause was an internal failure of the sensor.A manufacturing record evaluation was performed for the finished device, and no internal action was found during the review.The customer complaint regarding force sensor error was confirmed.Improvements have been implemented to reduce force sensor internal issues.This issue is highly detectable by the physician.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a procedure with a thermocool® smart touch¿ bi-directional navigation catheter, and a biosense webster, inc.Product analysis lab observed a cut on the surface of the pebax sleeve with internal parts exposed.Initially, during the ablation phase of a vt ablation, the hi force clash warning appeared as soon as radio frequency energy delivered.Each time this occurred, the force immediately prior to ablation was verified as being less than 10g and the catheter stability icon indicated a stable catheter position.The thermocool® smart touch¿ bi-directional navigation catheter was rezeroed to make sure that force reading prior to ablation was accurate.This did not resolve the issue.The catheter cable was changed.This did not resolve the issue.The catheter was changed which did resolve the issue.The procedure was continued and no patient consequence was reported.The high force issue was assessed as not mdr reportable.The issue was highly detectable when occurring.The potential that it could cause or contribute to a death, serious injury, or other significant adverse event was low.The biosense webster, inc.Product analysis lab received the device for evaluation and observed on june 12, 2020 reddish material in the pebax sleeve.No internal parts exposed.The foreign material found underneath the pebax was assessed as not mdr reportable since, there is no damage to the pebax integrity.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.During additional investigation on june 29, 2020, reddish material was observed inside the pebax as well as a cut on the surface of the pebax sleeve with internal parts exposed.The cut on the pebax sleeve was assessed as a mdr reportable issue.The awareness date for this reportable issue was june 29, 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: 10330884
• MDR Text Key: 202233229
• Report Number: 2029046-2020-00951
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 05/18/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2020
• Device Model Number: D132705
• Device Catalogue Number: D132705
• Device Lot Number: 30307566M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2019
• 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