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); Contamination /Decontamination Problem (2895)

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

Event Date 10/12/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the device evaluation has been completed.Upon receipt, the catheter was visually inspected, and it was found with a hole on pebax with reddish-brown material inside and internal parts exposed.A manufacturing record evaluation was performed for the finished device, and no internal action related to the reported complaint condition were identified.The customer complaint was confirmed.The root cause of blood trapped next to the electrode, inside the tip of the catheter could be related with the damage on pebax; however, it cannot be conclusively determined.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.All units are inspected prior leaving the facility and mre verified that this complaint unit was in good condition.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

A patient underwent an 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.It was initially reported by the customer that after the catheter was removed from the body, it was noticed that there was "blood trapped next to the electrode, inside the tip of the catheter." the catheter was flushed, to try and dislodge the blood residue, without resolution.The catheter was replaced, and the issue was resolved.The procedure continued.There was not patient consequence.The customer¿s reported issue of foreign material inside the pebax with no allegation of external damage is not considered to be mdr reportable since the integrity of the device was maintained.On 10/26/2020, the bwi product analysis lab received the complaint device for evaluation.On 12/2/2020, during the product evaluation, and a hole was found on a pebax with a reddish-brown material inside and internal parts exposed.The findings of a hole in the pebax has been assessed as an mdr reportable malfunction.

• 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: 11092344
• MDR Text Key: 251104145
• Report Number: 2029046-2020-02009
• 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: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30427409M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Date Manufacturer Received: 12/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2020
• 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