MAUDE Adverse Event Report: BIOSENSE WEBSTER INC LASSO® NAV ECO VARIABLE CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Catalog Number	D134302
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the device was visually inspected and a crack was observed between the spine cover and peek housing, internal parts were observed exposed.Then, an electrical test was performed and the catheter failed, no electrical readings were observed from electrode #1 to electrode #10, only the ring #11 and #12 were observed with electrical continuity, this failure is related to the damage observed on the spine cover.In addition, a scanning electron microscope (sem) testing was performed on the damaged area and the results showed evidence of mechanical damage, stress marks and a hole on the surface of the spine cover.It is possible that the damage was generated with an unknown object.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 the 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 was confirmed.The root cause of the damage on the spine cover cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures.(b)(4).
Event or Problem Description
It was reported that a patient underwent a procedure with a lasso® nav eco variable catheter.Originally it was reported that leads 1-6 were not working as there was no signal.There were no patient consequences reported.This signal issue on leads 1-6 was assessed as not reportable as the risk to the patient was low.The biosense webster failure analysis lab received the catheter for evaluation.It was discovered on (b)(6) 2018 that there was a crack between the spine cover and peek housing.Internal parts were exposed.On (b)(6) 2018 additional testing was performed on the damaged area.The scanning electron microscope (sem) results showed evidence of mechanical damage, stress marks and a hole on the surface of the spine cover.Since the catheter integrity was not maintained and internal components were exposed to the patient, this returned catheter condition was assessed as mdr reportable.The awareness date is (b)(6), 2018.

• Brand Name: LASSO® NAV ECO VARIABLE CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7836186
• Report Number: 2029046-2018-02004
• Device Sequence Number: 1517535
• Product Code: DRF
• UDI-Device Identifier: 10846835009644
• UDI-Public: 10846835009644
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K113213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/28/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/02/2021
• Device Catalogue Number: D134302
• Device Lot Number: 30027931L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 08/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1