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

Catalog Number D133604IL

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Contamination /Decontamination Problem (2895)

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

Event Date 04/19/2023

Event Type  malfunction  

Manufacturer Narrative

The ¿suspected medical device¿ reported in section d of this report is not marketed in usa or approved by the fda.However, it is being reported as biosense webster considers this as a similar device to thermocool® smart touch¿ electrophysiology catheter approved under pma # p030031/s053.The investigation was completed on 03-jul-2023.A picture and videos were received for evaluation following biosense webster's procedures.According to the videos and picture provided by the customer, the force value reaches the 20g, this could be considered a high force value; however, this cannot be conclusively determined.Also, reddish material (presumably blood) was observed inside the pebax; however, there is no evidence of an external damage on the pebax.The customer complaint was confirmed based on the videos and picture received.The product analysis was performed as appropriate in order to find the root cause of the complaint.The device was returned for evaluation.The returned device's visual inspection and screening tests were performed following biosense webster (bwi) procedures.Visual analysis of the returned device revealed reddish brown material inside and a hole on the pebax with internal parts exposed.The force feature was tested and no errors were observed.The force values and the vector were observed within specifications.No malfunction was observed.The events described were unable to be duplicated during the product investigation; however, the blood inside the pebax area found could be related to the reported issue.The instructions for use contain the following information that should be considered: to ensure accurate force readings, verify that the force reading is near zero when the catheter is not in contact with the tissue.If the force reading is not near zero when the catheter is not in contact with tissue, perform zeroing.A manufacturing record evaluation was performed for the finished device, and no internal actions related to the complaint were found during the review.Biosense webster¿s quality process ensures all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: picture/video analysis: -investigation findings: appropriate term/code not available (c22) / investigation conclusions: cause not established (d15) were selected as related to the picture/video provided.-investigation findings: operational problem identified (c13)/ investigation conclusions: cause not established (d15) / component code: sleeve (g04115) were selected as related to the customer¿s reported ¿blood that seemed to penetrate the spring part of the device¿ issue.Device analysis: -investigation findings: mechanical problem identified (c07) / investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: sleeve (g04115) were selected as related to the customer¿s reported ¿blood that seemed to penetrate the spring part of the device¿ issue and ¿high force value¿ issue.In addition to the biosense webster inc.Analysis finding of the ¿reddish brown material inside and a hole on the pebax with internal parts exposed¿ issue.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) procedure with a thermocool® smart touch¿ electrophysiology catheter for which biosense webster¿s product analysis lab (pal) identified a hole on the pebax with internal parts exposed.Initially reported force high and bleeding.During the procedure, the force value was high even though it had been zeroed multiple times.After removing the catheter from the patient, it was found that blood seemed to penetrate the spring part of the device as the photo and video show.A second device was used to complete the procedure.There was no adverse event reported on the patient.Additional information was received.The xinnupu 8.5 long sheath was used.It was not known if there was difficulty experienced while maneuvering the catheter or during the withdrawal.It was not known if the catheter pebax was physically damaged.The high force value issue was assessed as non mdr reportable.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.The blood that seemed to penetrate the spring part of the device issue was assessed as non mdr reportable.Since there is no damage to the pebax integrity, the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 03-jul-2023 there was reddish brown material inside and a hole on the pebax with internal parts exposed.The hole on the pebax with internal parts exposed was assessed as mdr reportable.The awareness date for this reportable lab finding was 03-jul-2023.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number:(b)(4) on (b)(6) 2023, the product investigation was reopened to clarify / correct the investigation findings which resulted in the following changes / corrections to include the following: the evaluation determined that the cause of pebax damage failure cannot be established.

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17439789
• MDR Text Key: 320240693
• Report Number: 2029046-2023-01648
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2023
• Device Catalogue Number: D133604IL
• Device Lot Number: 30967197M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2022
• 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
• Treatment: NON BWI - XINNUPU 8.5 LONG SHEATH.; UNKNOWN BRAND CATHETER.