MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) LASSO® 2515 NAV ECO VARIABLE CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Model Number D-1343-02-S

Device Problems Material Deformation (2976); Material Torqued (2980); Material Twisted/Bent (2981)

Patient Problem No Information (3190)

Event Date 03/17/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Event description continuation: the issue of wrinkled spine is not reportable and the potential that this issue could cause or contribute to a serious injury, significant adverse event or death is remote.The awareness date for this record is april 21, 2016 because that is when the reportable damage was discovered.The returned device was visually inspected upon receipt and lasso loop was found bent on the proximal side of ring #10 leaving spine cover wrinkled on both sides and proximal side of the ring was rough.In addition, a cut was observed with metal exposed.Per these conditions, the catheter outer diameters were measured and it was found within specifications.Then deflection and contraction tests were performed and the catheter passed even with the bent loop condition.Further information received indicates that during the procedure there was a lot of twisting and torque applied as the physician tried to torque it into a pulmonary vein.This manipulation might contribute to the deformed shape.Additionally the cut observed was not detected post procedure; it might happen while the catheter was shipped back to bwi for analysis.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 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.The reported customer complaint regarding a misshaped loop has been verified.Based on available analysis finding results, the failure mode does not appear to be caused by any internal bwi processes.

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a lasso 2515 nav eco variable catheter and the lasso loop became deformed.The deformity was noticed upon removal of the catheter after use.The catheter was removed without incident and was intact.The procedure was completed with no patient consequence.This event was originally assessed as not mdr reportable because the overall health risk to the patient is low as the most likely harm is an intra-procedural delay.The device was returned to the biosense webster failure analysis lab for analysis and it was discovered that the lasso loop was bent in a downward position on the proximal side of ring #10 leaving the spine cover wrinkled on both sides.About 1mm from the distal side of ring #10, the spine cover was cut open with metal and clear plastic material exposed.Ring #10 on the proximal side was lifted up above the polyurethane margin leaving it rough.Additional information was received on the returned catheter condition.During use there was a lot of twisting and torque applied as the physician tried to torque it into a pulmonary vein.It is unknown if there was difficulty removing the catheter through the medtronic flexcath 12-14french sheath, but there is a chance with the bend shape that it could have been damaged during removal.There was no change in signal quality during voltage mapping.The returned catheter condition was not present prior to use as it was in normal condition.However, the condition was somewhat recognized upon withdrawal.The bent shape was noticed, however the wire exposed was not seen prior to sending the catheter back.The returned catheter condition is mdr reportable because the integrity of the catheter has been compromised with the exposed wire which poses a potential risk to the patient.The rough surface of the electrode also poses a risk to the vasculature of the patient.

• Brand Name: LASSO® 2515 NAV ECO VARIABLE CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• 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: 5656842
• MDR Text Key: 46474661
• Report Number: 9673241-2016-00330
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/17/2016

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: 12/31/2018
• Device Model Number: D-1343-02-S
• Device Catalogue Number: D134302
• Device Lot Number: 17398235L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/17/2016
• Initial Date FDA Received: 05/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2016
• 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