MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134801

Device Problems Material Puncture/Hole (1504); Contamination /Decontamination Problem (2895); Device-Device Incompatibility (2919); Sharp Edges (4013)

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

Event Date 08/06/2021

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 a visual inspection and dimensional analysis of the returned device.Visual inspection of the returned sample revealed that reddish material was found inside the pebax.Electrode #2 was found dented and without polyurethane adhered to the edge, exposing the internal components.The blood in the coil, as documented in the event description, entered through an opening in the pebax caused by the damaged electrode and lack of polyurethane.The dimensional analysis confirmed that catheter measurements are within specifications.Based on the findings noted above, the customer complaint was confirmed.Assignment of root cause for the event remains inconclusive based on the information available for review.However, there are clinical and procedural factors that may have contributed rather than the design or manufacture of the device; there is evidence that the device was manufactured in accordance with documented specifications and procedures.In addition, pictures provided of the complaint device showed electrode #2 was lifted and damaged.Also, foreign material was observed inside the pebax.The customer complaint was also confirmed based on the pictures received.A manufacturing record evaluation was performed, and no internal action was found during the review.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.(b)(4).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

A patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified electrode damage and an opening in the junction of the pebax and electrode # 2.It was initially reported by the customer that after the thermocool® smart touch® sf bi-directional navigation catheter was inserted and after mapping, one (1) hour after starting the use of the catheter, when catheter tip was checked, blood was trapped in the coil and could not be removed.There was no error code etc.The thermocool® smart touch® sf bi-directional navigation catheter was exchanged to continue the procedure and prevent thrombosis.Additional information was later received indicating there was catheter resistance during catheter insertion, but no physical damage to the pebax.An abbot, 8.5fr, agilis short sheath was used during the procedure.The customer¿s reported resistance with the sheath issue is not considered to be mdr reportable issues since interference or friction between devices is a known occurrence.If resistance is encountered, the system may be withdrawn as a unit.This is a common practice during procedures.Since the vast majority of ep procedures utilize multiple device exchanges, an increased potential for patient injury is remote.The customer¿s reported foreign material in the pebax, no external damage, is also not mdr reportable since foreign material was found underneath the pebax.However, there is no damage to the pebax integrity that could cause the foreign material travels into the blood circulation.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On 25-oct-2021, an investigation for photo analysis was completed.The investigation found electrode #2 was observed lifted and damaged.This finding of electrode damage was reviewed and assessed as an mdr reportable malfunction.On 16-nov-2021, the product returned evaluation was completed.The product evaluation determined there was a reddish material found inside the pebax.Electrode #2 was found dented and without pu (polyurethane) adhered to the edges, exposing the internal components.No puncture or crack was found on the pebax surface; however, it has an opening at the junction with the electrode #2.This finding of an opening in the material which exposes internal components has been assessed as an mdr reportable malfunction.

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12837875
• MDR Text Key: 282293579
• Report Number: 2029046-2021-02004
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2022
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30537279M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Date Manufacturer Received: 10/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2021
• 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: ABBOT, 8.5FR, AGILIS SHORT SHEATH; THMCL SMTCH SF BID, TC, D-D