MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D-1348-01-S

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2017

Event Type  malfunction  

Manufacturer Narrative

Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).

Event Description

It was reported that a patient underwent a procedure with a thermocool smart touch bidirectional sf catheter where the tip of the catheter was torn.During the procedure, the catheter was inserted into the patient.The physician noted that the catheter felt cooler than usual, so it was removed from the patient¿s body, at which point it was found that the catheter tip was partially torn.The catheter was exchanged for a new one, and the procedure continued without patient consequence.It is not known if the damage resulted in wires or braid being exposed, but there were no lifted or sharp rings.The sheath in use in unknown.There was noted difficulty during the insertion of the catheter.A torn catheter tip could expose the patient to the internal catheter components, creating a potential risk of patient harm.As a result, this event is mdr reportable.

Manufacturer Narrative

On 9/22/2017, the bwi failure analysis lab received the device for evaluation.A visual inspection of the device found that the first electrode was lifted and sharp with foreign material underneath it.Additionally, there was a scratch on the pebax approximately 1/2 mm from the distal side of the second electrode.Multiple attempts were made to obtain additional information regarding the observed damage, but none was made available.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Manufacturer¿s reference number: (b)(4).

Manufacturer Narrative

On 10/11/2017, biosense webster received additional information regarding this complaint file: the catheter condition was not noted prior to use, nor prior to sending it back for analysis.Manufacturer¿s reference number: (b)(4).

Manufacturer Narrative

Manufacturer's reference number: (b)(4).It was reported that a patient underwent a procedure with a thermocool smart touch bidirectional sf catheter where the tip of the catheter was torn.The returned device was visually inspected, and the 1st electrode was found damaged.The electrode was sharp and lifted on both sides with white plastic foreign material underneath.A small scratch was present on the pebax with no metal exposed.The catheter outer diameter was measured, and was found within specifications.Per the observed damage, scanning electron microscope (sem) analysis was performed.The results showed evidence of mechanical damage on the surface of the electrode, and the pebax showed scratches, but no holes.It is possible that the damage was caused by contact with an unknown object.No other anomalies were observed.Per the presence of foreign material, fourier transform infrared spectroscopy (ft-ir) was performed.The results showed that the foreign material was primarily composed of polyethylene.A second compound within the polyethylene was also identified by the ir spectroscopy test.This compound presumably corresponds to barium sulfate, a material widely used as a radio pacifier among medical device industries.The device history record (dhr) was reviewed, and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.During the manufacturing process, all catheters are inspected for visual damage prior to packaging.On-line inspections and functional tests are in place to prevent catheters with this type of damage from leaving the facility.The customer complaint has been verified.Based on the available analysis finding results, the damage on the ring and pebax does not appear to be caused by any internal bwi processes.There is evidence that the device was manufactured in accordance with documented specification and procedures.The damage could be related to the manipulation of the catheter within the sheath, but this cannot be conclusively determined.

• Brand Name: THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6798173
• MDR Text Key: 85019643
• Report Number: 9673241-2017-00650
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: (01)10846835010145(11)170207(17)180131(10)17631499L
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: D-1348-01-S
• Device Catalogue Number: D134801
• Device Lot Number: 17631499L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2017
• 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