MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THMCL SMTCH SF BID, TC, D-F; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D134805

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2019

Event Type  malfunction  

Manufacturer Narrative

The biosense webster inc.(bwi) product analysis lab (pal) received the device for evaluation.The investigational analysis completed 11/27/2019.The device was inspected and the pebax sleeve was found with scratches and reddish brown material inside, with no metal exposed.Initial findings were confirmed during a second visual.During the second visual inspection reddish material, a dented dome and dented rings were observed.Additionally, a cut on the surface of pebax sleeve was observed, exposing internal parts.The 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 and no internal actions were identified.The customer complaint was confirmed.The root cause of the internal failure of the force sensor could be related to the design.The root cause of the damage on pebax, rings, and dome 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 shipping.However, this cannot be conclusively determined.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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 catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found a cut on the surface of pebax sleeve.Initially, it was reported that a catheter sensor error displayed on the carto 3 system.The catheter was re zeroed and the issue remained.The catheter was replaced, and the issue resolved.No adverse patient consequences were reported.The observed force sensor error 106 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 10/14/2019, the bwi pal received the device for evaluation.Upon initial inspection, the pebax sleeve was observed with scratches and reddish brown material inside.Additionally, tip dome, ring #1, ring #2, and ring #3 were all observed dented on the same side.These initial findings have been assessed as not mdr reportable, as device integrity was maintained and no metal was exposed.On 11/7/2019, a second visual inspection was performed.Reddish material, dented rings, a dented dome, and a cut on the surface of the pebax sleeve was observed.The observed cut on the pebax sleeve has been assessed as an mdr reportable malfunction as internal parts exposed.The awareness date has been reset to 11/7/2019.

• Brand Name: THMCL SMTCH SF BID, TC, D-F
• 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: 9403624
• MDR Text Key: 195391497
• Report Number: 2029046-2019-03949
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2020
• Device Catalogue Number: D134805
• Device Lot Number: 30240533M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Date Manufacturer Received: 11/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2019
• 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