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

Model Number D-1343-01-S

Device Problems Sticking (1597); Dent in Material (2526); Material Twisted/Bent (2981); Scratched Material (3020)

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

Event Date 02/17/2015

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a lasso 2515 nav eco variable catheter and experienced deflection difficulties which is not a reportable malfunction.When catheter was changed issue resolved.There was no patient consequence.On (b)(6) 2015 bwi failure analysis lab received the device for evaluation and found that lasso loop has been twisted in upward position and ring #1 is dented in the middle.Which are not reportable findings.However, it was also found that spine cover has surface cut leaving material sticking up on distal side of ring #3, ring #12 on distal side has a very small piece of white material stuck underneath it and little sticking out, ring #13 has white material stuck underneath it on distal side, ring #16 has white material stuck underneath it on distal side and ring #20 is squashed, sharp with white material underneath it in two places.These findings are reportable because electrode ring edges appear to be sharp or rough which may cause damage to vascular endothelial linings during the withdrawal of the catheter and sheath.In addition, dislodgement of the foreign material inside the patient poses a risk of embolus.

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.As lot # 17170442l was provided, the device history record(s) 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.(b)(4).

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a lasso® 2515 nav eco variable catheter and experienced deflection difficulties which is not a reportable malfunction.When catheter was changed issue resolved.There was no patient consequence.On (b)(4) 2015 bwi failure analysis lab received the device for evaluation and found that lasso loop has been twisted in upward position and ring #1 is dented in the middle.Which are not reportable findings.However, it was also found that spine cover has surface cut leaving material sticking up on distal side of ring #3, ring #12 on distal side has a very small piece of white material stuck underneath it and little sticking out, ring #13 has white material stuck underneath it on distal side, ring #16 has white material stuck underneath it on distal side and ring #20 is squashed, sharp with white material underneath it in two places.These findings are reportable because electrode ring edges appear to be sharp or rough which may cause damage to vascular endothelial linings during the withdrawal of the catheter and sheath.In addition, dislodgement of the foreign material inside the patient poses a risk of embolus.The bwi failure analysis lab received the device for evaluation.The returned device was found well joined to tip section with pu, there was no spinning issues or other unusual condition.The rings condition was not originally reported on the complaint, and additional information was tried to obtain; nevertheless, it was not possible.However, the type of damage suggests that the catheter had friction with another device possibly the sheath from distal to proximal causing the rings to be uplifted.However, it could not be conclusively determined sem results showed that the rupture observed presented evidence of damages induced by a sharp object.Rings analyzed presented evidence of deformations by a compression condition.No other issues were found during sem analysis that could be related to the reported condition.Infrared spectroscopy was applied to identify the chemical composition of a foreign particle found on a lasso nav variable eco catheter.The ir data obtained from the particle analyzed, revealed that particle is primarily composed of a styrene-based material, presumably the copolymer known as abs.Per this condition the catheter outer diameters were measured and it was found within specifications.Per the complaint, the catheter was tested for deflection and contraction test and the catheter pass during deflection test.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 cannot be confirmed.

• 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 3259 9; MX 32599
• Manufacturer Contact: shahe garabedian ; 9098397362
• MDR Report Key: 4798229
• MDR Text Key: 20725059
• Report Number: 9673241-2015-00321
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K113213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2015

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: 12/31/2017
• Device Model Number: D-1343-01-S
• Device Catalogue Number: D134301
• Device Lot Number: 17170442L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2015
• Initial Date FDA Received: 05/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2015
• 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