MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER

Model Number D-1347-01-SI

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2017

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.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a thermocool® smarttouch® sf uni-directional nav catheter and the catheter was broken.No other information could be provided.The catheter was replaced and the issue resolved.The procedure was completed with no patient consequence.Multiple attempts have been made to obtain clarification in this complaint.However, no further information has been made available.This event was originally assessed as not mdr reportable because the issue cannot be assessed for malfunction, as the nature of the failure is unknown.With the information available no risk to patient safety can be identified.On (b)(6) 2017 the biosense webster failure analysis lab discovered reddish brown material inside the clear sensor sleeve with no holes.This finding was assessed as not mdr reportable; the presence of reddish brown material is an expected finding after these procedures.In addition, if catheter integrity is maintained and no internal components are exposed to the patient, then the potential that this issue could cause or contribute to a death, serious injury, or other significant adverse event is remote.On (b)(6) 2017, the biosense webster failure analysis lab discovered reddish brown material inside the clear sensor sleeve.A pinhole was observed in the pebax.The pinhole in the pebax is mdr reportable.The presence of a pinhole creates a break in the integrity of the catheter.The risk to the patient is critical due to the potential of thrombus from exposure to internal catheter.The awareness date has been reset to (b)(6) 2017, the date the reportable finding was discovered.

Manufacturer Narrative

Manufacturer's ref.(b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a thermocool® smarttouch® sf uni-directional nav catheter and the catheter was broken.The returned device was visually inspected upon receipt and reddish material was found inside the pebax and a pinhole was observed.Per this condition a scanning electron microscope (sem) testing was performed.Results show that the pebax external surface presented evidence of scratches and pinholes.It is possible that an unknown object hits and punctures the pebax surface.No other anomalies were observed.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 manufacturing process all the catheters are inspected for visual damages before packaging.On line inspections and functional tests are in place to prevent this type of damage from leaving the facility.The customer complaint cannot be verified.The damage might be related to the pericardial effusion, however this cannot be conclusively determined since there is inspection to prevent this type of damage.

Manufacturer Narrative

During a clinical trial sponsored by bwi, it was reported that a (b)(6) male patient underwent an ablation procedure for persistent atrial fibrillation with a thermocool® smarttouch® sf uni-directional nav catheter and suffered a cardiac tamponade requiring pericardiocentesis and medication (unspecified).Post-procedure, a tamponade was detected.Pericardiocentesis was performed and yielded an unspecified amount of fluid.Medication (unspecified) was administered.Patient required extended hospitalization as a result of the adverse event.Issue resolved without sequelae.Cardiovascular medical history includes coronary disease, left ventricular systolic dysfunction, and vascular disease.Principal investigator assessed this event as moderate in severity, serious, not device-related, and definitely index procedure-related.(b)(4).

• Brand Name: THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV 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: 6497950
• MDR Text Key: 73334952
• Report Number: 9673241-2017-00287
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• 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,Followup
• Report Date: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: D-1347-01-SI
• Device Catalogue Number: D134701SI
• Device Lot Number: 17464140L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/31/2016
• 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