MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Model Number D-1336-04IL-S

Device Problems Bent (1059); Hole In Material (1293); Stretched (1601); Device Contamination with Chemical or Other Material (2944); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/18/2016

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.(b)(4).

Event Description

It was reported that a patient underwent a procedure with a smart touch unidirectional catheter.During the procedure, the physician found that the tip of the catheter was curved.No wires were exposed.There was no reported lifted or sharp rings.It was not reported if the catheter was pre-shaped.The sheath information was not reported.There was no resistance or difficulty during insertion or removal of the catheter.The catheter was exchanged.The procedure was completed with no patient consequence.This reported issue was assessed as a not reportable as the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The biosense webster failure analysis lab received the catheter for analysis and discovered on (b)(6) 2016 that the proximal side of ring #1 that the polyurethane (pu) margin and the helix spring was bent causing the clear sensor sleeve to be bent, stretched, and wrinkled with small holes allowing reddish brown residues inside the sensor sleeve area.Additional analysis was performed and it was confirmed that the external surface exhibited evidence of rupture between the pu and pebax.The presence of holes in the sensor sleeve was assessed as a reportable malfunction as it presented the risk of contamination and internal parts being exposed to the patient.The awareness date was reset to (b)(6) 2016.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent a procedure with a smart touch unidirectional catheter.During the procedure, the physician found that the tip of the catheter was curved.No wires were exposed.There was no reported lifted or sharp rings.It was not reported if the catheter was pre-shaped.The sheath information was not reported.There was no resistance or difficulty during insertion or removal of the catheter.The catheter was exchanged.The procedure was completed with no patient consequence.The returned device was visually inspected upon receipt a helix spring was found bent causing the clear sensor sleeve to be stretched wrinkled and with small holes allowing reddish brown residues inside the area.A tilt test was performed and catheter failed; however during manufacturing process all the catheters are inspected for visual damages before packaging.On line inspections are in place to prevent this type of damage/defect from leaving the facility.A scanning electron microscope (sem) test was performed and it was found and the body external surface presented evidence of scratching and rupture induced by an unknown object.The catheter outer diameters were measured and were found within specifications.The bent condition might be a result to the manipulation of the device during the procedure; however this cannot be conclusively determined.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.The customer complaint has been verified.Based on available analysis finding a result, the failure mode does not appear to be caused by any internal biosense webster inc.Processes; since several inspections are in place to prevent this device condition.

• Brand Name: THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• 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: 6003011
• MDR Text Key: 57271745
• Report Number: 9673241-2016-00661
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: D-1336-04IL-S
• Device Catalogue Number: D133604IL
• Device Lot Number: 17340161M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2015
• 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