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

Catalog Number D133604IL

Device Problems Image Orientation Incorrect (1305); Contamination /Decontamination Problem (2895)

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

Event Date 04/10/2023

Event Type  malfunction  

Manufacturer Narrative

Device investigation details: a picture was received from the customer to aid in the product investigation.Evaluation was performed following biosense webster's procedures.According to pictures provided by the customer, reddish material was observed inside the pebax; however, no external damage was observed in this section.Also, the photo does not provided sufficient information related to the vector inverted event reported by the customer, and therefore no results can be obtained from it.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed based on the picture received.The device has not been returned for analysis and a root cause is unable to be assigned based on the current evidence.If the device is received in the future, the product investigation will be performed and updated accordingly, and any action will be taken if necessary.Note: 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 (b)(4).Note: the h6.Investigation findings code of ¿appropriate term/code not available (c22)¿ used to represent the photo analysis results.E1.Initial reporter phone: (b)(6).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

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and external damage in the pebax (spring area) was identified.It was initially reported by the customer that during the operation, the force vector displayed on the carto was inverted.Also, the spring area of the device was found damaged after removing the device from the patient.A synaptic l1 sheath was used a second device was used to complete the operation.There was no adverse event reported on patient.The customer¿s reported issue of inverted force vector is not mdr reportable since despite the incorrect force vector visualization, the device can function as intended, because the catheter can still be displayed using fluoroscopy and carto 3 navigation system.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The risk to the patient is low.

Manufacturer Narrative

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and external damage in the pebax (spring area) was identified.It was initially reported by the customer that during the operation, the force vector displayed on the carto was inverted.Also, the spring area of the device was found damaged after removing the device from the patient.A synaptic l1 sheath was used a second device was used to complete the operation.There was no adverse event reported on patient.On 12-jun-2023, additional information was received indicating the date of event was actually 10-apr-2023 and not 11-apr-2023 as previously reported.Field b3 has been updated accordinly.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection evaluation and screening test of the returned device were performed following bwi procedures.Visual inspection was performed, and a reddish material was observed inside the pebax with a hole on the surface.Also, foreign material was observed underneath an electrode.Then, a screening test was performed, and high force values and inverted vector were observed intermittently in a deflected position.Then, a fourier transform infrared (ft-ir) analysis was performed to the foreign material and it was concluded that is primarily composed of a polyethylene ¿ based material, which is widely used as a radio pacifier along medical device industries.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issues reported by the customer were confirmed.The reddish material inside the pebax could be related to the force issue reported by the customer.Also, the pebax damage and the particle underneath the electrode could be related to the interaction between the device and the sheath used during the procedure however, this cannot be conclusively determined.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: inappropriate material (c0602) / investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: electrode (g0201501) were selected as related to the issue of foreign material under the electrode.Investigation findings: material and/or chemical problem identified (c06) / investigation conclusions: cause not established (d15) / component code: sleeve (g04115) were selected as related to the hole in the pebax.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

On 17-may-2023, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• 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: 16875024
• MDR Text Key: 314625334
• Report Number: 2029046-2023-00966
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2023
• Device Catalogue Number: D133604IL
• Device Lot Number: 30946277M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2022
• 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: SYNAPTIC L1 SHEATH.; THMCL SMARTTOUCH,TC,D,C3,OBL.