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

Model Number D-1282-07-S

Device Problems Physical Resistance (2578); Physical Property Issue (3008)

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

Event Date 12/19/2016

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.The lot number is 17553595l.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a pentaray navigational eco catheter.It was reported that after passing the pentaray catheter through the agilis large curve sheath with force, a piece of plastic was visualized by ultrasound on the pentaray catheter.The catheter was replaced and the issue resolved.The procedure was completed with no patient consequence.The resistance with the sheath in itself was assessed as not reportable.Interference or friction between devices is a known occurrence.If resistance is encountered, the system may be withdrawn as a unit.This is a common practice during procedures.Since the vast majority of ep procedures utilize multiple device exchanges, an increased potential for patient injury was remote.The issue with the reported plastic was assessed as a reportable malfunction.Foreign material that was found adhered to the catheter within the usable length during or after the procedure, including plastic, pose a risk to the patient.

Manufacturer Narrative

During additional analysis, the biosense webster, inc.Found one electrode folded up and there was also damage found between electrodes 21-22.Per the issue found, a scanning electron microscope (sem) testing was performed over the damaged area of the catheter and there was evidence of a hole and scratches on the surface of the peek housing.Additional clarification was received on the catheter conditions noted which stated that the ring issue was noticed after removing the catheter from the patient.The ring issue may cause damage to vascular endothelial linings during the withdrawal of the catheter and sheath.The hole between electrodes 21-22 reflects that the integrity was compromised.The scratches to the peek housing reflects that the integrity was maintained in this area as no internal components were exposed to the patient.(b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a pentaray navigational eco catheter.It was reported that after passing the pentaray catheter through the agilis large curve sheath with force, a piece of plastic was visualized by ultrasound on the pentaray catheter.The catheter was replaced and the issue resolved.The procedure was completed with no patient consequence.The returned device was visually inspected and no foreign material was observed in the catheter.However, damage was found between electrodes 21-22, likewise one electrode was found folded up side proximal.Per this condition, a scanning electron microscope (sem) testing was performed over the damaged area of the catheter and evidence of a hole and scratches on the surface of the peek housing.It is possible that the damage was generated with an unknown object.Finally, the catheter outer diameters were measured and it was found within specifications.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 based on available analysis results the procedural/handling factors may contribute to the catheter failure; the failure mode does not appear to be caused by any internal biosense webster, inc.Processes since during manufacturing process all the catheters are inspected for visual damages before packaging.

• 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: 6252921
• MDR Text Key: 65262854
• Report Number: 9673241-2017-00048
• 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: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: D-1282-07-S
• Device Catalogue Number: D128207
• Device Lot Number: 17553595L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2016
• 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