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

Catalog Number D133604IL

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

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

Event Date 01/26/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the product was returned to biosense webster for evaluation and the evaluation has been completed.Visual inspection and functional testing were conducted on the returned device.The visual analysis of the returned sample revealed that the thermocool® smart touch¿ electrophysiology catheter was received with a reddish material inside the pebax.A microscopic inspection revealed that the pebax has a hole on it.During the deflection test, it was noted that the catheter failed, as such, the catheter was dissected and it was found that the t-bar slid down from its place.Based on this finding, the customer complaint was confirmed.The evaluation determined that the blood inside the pebax area found could not be related to the reported issue.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.A manufacturing record evaluation was performed, and no internal actions were identified.As part of the biosense webster quality process, all devices are manufactured, inspected, and released to approved specifications.A deflection issue was observed during evaluation and the reported event was confirmed.The product instructions for use (ifu) contain the following recommendations: always pull the thumb knob back to straighten the catheter tip before insertion or withdrawal of the catheter.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Initial reporter phone: (b)(6).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 reddish material inside the pebax area and a hole in the pebax as well.It was initially reported that during the procedure, the catheter was unable to deflect or relax completely.A second catheter was used to complete the operation.There was no patient consequence.The customer¿s reported deflection issue was assessed as not mdr reportable since the most likely consequence is an intraprocedural delay and the potential risk that it could cause or contribute to a serious injury or death is remote.On 3/3/2021, the bwi product analysis lab received the complaint device for evaluation.On 3/10/2021, the complaint catheter was inspected and found with a reddish material inside the pebax and the pebax has a hole on it¿s surface.This finding of hole in the pebax has been assessed as 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 3/10/2021 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: 11631953
• MDR Text Key: 266107305
• Report Number: 2029046-2021-00540
• 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: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2021
• Device Catalogue Number: D133604IL
• Device Lot Number: 30463080M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Date Manufacturer Received: 03/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2020
• 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