MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number D-1282-11-S

Device Problems Bent (1059); Folded (2630)

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

Event Date 12/02/2016

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.Concomitant products: smart touch catheter, model # d-1327-05-s, lot # 17580572m.Smart touch catheter, model # d-1327-05-s, lot # 17553109m.Smartablate generator.Carto 3 system.St.Jude medical agilis 8.5fr sheath.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a pentaray nav eco catheter where the spines became bent.Halfway through the procedure, it was found that the spines on the pentaray catheter had lost their shape.There were minor bends reported, but no wires were exposed.No difficulty was reported with removing the catheter, but there was some difficulty inserting it.The pentaray catheter was replaced, and the case continued without any report of patient consequence.On (b)(6) 2017, the biosense webster failure analysis lab found that the top ring on the catheter was folded back and lifted with a sharp edge.Additionally, the second ring was smashed, creating sharp edges on the sides.The damage was not noted prior to use of the catheter, upon withdrawal, or prior to sending the catheter back.The sheath in use was a st.Jude medical agilis 8.5fr.If electrode ring edges are sharp or rough, they can cause damage to vascular endothelial linings during withdrawal of the catheter/sheath.As a result, this event is mdr reportable.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an ablation procedure for atrial fibrillation with a pentaray nav eco catheter where the spines became bent.The returned device was visually inspected, and two spines were found folded back.Additionally, some electrodes were found damaged, with lifted and sharp rings.Per this condition, the catheter outer diameters were measured and were found within specifications.The polyurethane margins were found to be properly applied.During the manufacturing process, all catheters are inspected for visual damage prior to packaging.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.However, the root cause of the failure could not be conclusively determined during analysis.Based on the available analysis finding and results, the failure mode does not appear to be caused by any internal bwi processes.There is evidence that the manufacturing process was followed properly.

• Brand Name: PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• 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: 6274901
• MDR Text Key: 65973763
• Report Number: 9673241-2017-00071
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123837
• 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
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: D-1282-11-S
• Device Catalogue Number: D128211
• Device Lot Number: 17593054L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2016
• 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