MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D133605IL

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

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

Event Date 12/31/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation and the evaluation has been completed.Bwi conducted visual inspection, microscopic examination and irrigation test of the returned device.Visual analysis of the returned catheter revealed reddish material inside the pebax and a hole on the surface of the pebax.A cool flow pump test was performed and it was found within specifications, the catheter was irrigating correctly, no irrigation issues were observed.A manufacturing record evaluation was performed for the finished device and no internal actions were identified.As part of bwis quality process, all devices are manufactured, inspected, and released to approved specifications.Regarding the additional finding observed, the instruction for use contains the following information: in order to prevent damage to the catheter tip, use the insertion tube supplied with the catheter to advance or retract the catheter through the hemostasis valve of the sheath.The event described could not be confirmed as the as the device performed without any irrigation issues.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.(b)(4).Investigation findings: no device problem found / investigation conclusions: no problem detected selected in relation to the customers reported catheter leak.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 atrial fibrillation (afib) ablation procedure with a thermocool¿ smart touch" electrophysiology catheter for which biosense websters product analysis lab identified a hole on the pebax.It was initially reported by the customer that during the afib operation, fluid (saline solution) escaped from an unintended location of the catheter (handle, luer hub or shaft).A second catheter was used to complete the operation.There was patient consequence.The customers reported leaking catheter issue was assessed as not mdr reportable since the issue is highly detectable by the physician.The most likely consequence is an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote on 01/28/2021, the bwi product analysis lab received the complaint device for evaluation.On 03/11/2021, during further evaluation the catheter was inspected and it was found with a reddish material inside the pebax and a hole on its surface of the pebax.This issue of a hole in the pebax was reviewed and determined to be an mdr reportable malfunction since the integrity of the device has been compromised.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through product analysis on 03/11/2021 and reassessed it as mdr reportable.

• Brand Name: THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• 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: 11637563
• MDR Text Key: 266050935
• Report Number: 2029046-2021-00547
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2021
• Device Catalogue Number: D133605IL
• Device Lot Number: 30363970M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Date Manufacturer Received: 03/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1