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

Model Number D-1348-04-S

Device Problems Thermal Decomposition of Device (1071); Crack (1135); Device Operates Differently Than Expected (2913); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2017

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation.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.Concomitant products: st.Jude medical agilis 8.5fr sheath, lot number unknown.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a thermocool smart touch bidirectional sf catheter where the deflection mechanism stopped functioning.Approximately halfway through the procedure, the catheter stopped deflecting towards the f curve.The catheter was replaced, and the case continued without patient consequence.If the catheter cannot deflect or relax completely, it cannot be used and must be replaced.The potential that a catheter with this issue could cause or contribute to an adverse event is remote.This is not an mdr reportable event.On 8/16/2017, the biosense webster failure analysis lab received the device for evaluation, and found that the peek housing/tip lumen transition was cracked with reddish brown material inside and exposed metal.There were also white bumps approximately 2.4mm from the cracked transition area.No metal was exposed in this area.There was no noted difficulty during the insertion or withdrawal of the catheter.The damage was not noted prior to use, upon withdrawal, or before returning the catheter for analysis.A st.Jude medical agilis 8.5fr sheath was in use.The presence of reddish brown material inside the catheter is an expected finding after a procedure of this type, and is not mdr reportable.The white bumps found near the tip lumen/peek housing transition are also not reportable, as the catheter integrity was maintained in this area.Since there was no evidence that the catheter integrity had been compromised, the potential that this could cause or contribute to an adverse event is remote.However, the crack in the transition near the peek housing/tip lumen is reportable, as exposure to the internal catheter components creates a critical risk of thrombus formation.The awareness date for this complaint has been reset to 8/16/2017, the date of the reportable finding.

Manufacturer Narrative

Manufacturer's reference number: (b)(4).It was reported that a patient underwent an ablation procedure for atrial fibrillation with a thermocool smart touch bidirectional sf catheter where the deflection mechanism stopped functioning.On 8/16/2017, the biosense webster failure analysis lab received the device for evaluation, and found that the peek housing/tip lumen transition was cracked with reddish brown material inside and exposed metal.The returned device was visually inspected, and the peek housing was found cracked, with reddish material in the area and exposed metal.Additionally, white bumps were observed near that area.Per the reported event, a deflection test was performed, which the catheter failed.The catheter was observed under x-ray, and the t-bar was found to have slid down from its place.The catheter was dissected, and polyurethane residues and reddish material were found at the t-bar anchor, indicating proper assembly during manufacturing.Catheter deflection is verified several times prior to leaving the facility.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.The root cause of the catheter t-bar displacement cannot be determined, since there was evidence of proper assembly during manufacturing.The root cause of the damage observed at the peek housing area is related to the t-bar displacement, as this causes stress on the catheter.

• 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: 6813897
• MDR Text Key: 83747386
• Report Number: 9673241-2017-00671
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: (01)10846835010176(11)170612(17)180531(10)17682731L
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: D-1348-04-S
• Device Catalogue Number: D134804
• Device Lot Number: 17682731L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2017
• Initial Date FDA Received: 08/23/2017
• Supplement Dates Manufacturer Received: 07/25/2017
• Supplement Dates FDA Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2017
• 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