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

Model Number D134805

Device Problems Material Puncture/Hole (1504); Failure to Sense (1559)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.Device evaluation details: the device was visually inspected and it was found foreign material inside the pebax with no visible external damage.After that, the force functionality was tested on carto 3 system and no errors appeared.The device was working within specifications.Due to the reddish material observed inside the pebax, sem analysis (scanning electron microscopy) was performed and evidence of mechanical damage and a hole was found on the pebax surface.A manufacturing record evaluation was performed for the finished device 30404992m number, and no internal actions related to the reported complaint condition were identified.The customer complaint regarding force issue was unable to duplicate during the product investigation however, the foreign material found inside the pebax area could be related to the reported issues.The root cause of the pebax damage cannot be fully determined, it could be related to the usage 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

A patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab identified a hole on the pebax surface with foreign material inside.During the procedure, there was a force streaming error #106 when the smart touch catheter was connected to the patient interface unit on the carto 3 system.The catheter cable was changed but the issue persisted.The catheter was replaced and the issue resolved.The procedure was continued and subsequently completed.No patient consequences were reported.The force streaming error is not an mdr-reportable issue.The hole in the pebax is mdr-reportable.The foreign material is mdr-reportable.".

• 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
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 11017402
• MDR Text Key: 225008207
• Report Number: 2029046-2020-01941
• 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: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30427552M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Date Manufacturer Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2020
• 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