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

Catalog Number D133605IL

Device Problems Material Puncture/Hole (1504); Positioning Problem (3009)

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

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the catheter was returned to biosense webster for evaluation.The evaluation has been completed.Bwi conducted a visual inspection and deflection evaluation of the returned catheter.Visual analysis of the returned sample revealed reddish material inside the pebax on the thermocool® smart touch¿ electrophysiology catheter deflection test was performed, in accordance with bwi procedures.The catheter passed deflection within specifications.Scanning electron microscope (sem) results show evidence of mechanical damage and a hole on the pebax surface.Object that caused the damage is unknown.No other anomalies were observed.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.The customer¿s reported deflection issue could not be confirmed as the as the catheter performed without any deflection issues.The evaluation determined that the cause of pebax damage failure cannot be established.Additionally, the customer had provided a photo of the complaint device to aid in the investigation.This investigation was performed based and determined that based only on the photo provided, the customer¿s complaint could not be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# pc-(b)(4).

Event Description

A patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter for which biosense webster¿s product analysis lab identified a hole in the pebax.It was initially reported by the customer that during the ablation procedure a deflection issue was encountered as the catheter was unable to deflect or relax completely.A second catheter was used to complete the operation.There was no patient consequence reported.The customer¿s reported deflection issue was assessed as not reportable since the most likely consequence is an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death is remote.On 2/26/2021, the bwi product analysis lab received the complaint device for evaluation.On 3/9/2021, the catheter was inspected and found with a reddish material inside the pebax.As such, on 3/10/2021 a scanning electron microscope (sem) analysis was done to identify if the integrity of the pebax was compromised.The sem results showed evidence of mechanical damage and a hole on the pebax surface.These findings were reviewed and determined the issue of a ¿hole¿ in the pebax is an mdr reportable malfunction since the integrity of the device was compromised.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through sem analysis on 3/10/2021 and reassessed t 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: 11632730
• MDR Text Key: 266388754
• Report Number: 2029046-2021-00542
• 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: 01/28/2021

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: 08/10/2021
• Device Catalogue Number: D133605IL
• Device Lot Number: 30405225M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Date Manufacturer Received: 03/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2020
• 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