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

Catalog Number D128211

Device Problems Bent (1059); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2018

Event Type  malfunction  

Manufacturer Narrative

Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.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.(b)(6).(b)(4).

Event Description

It was reported that a patient underwent an atypical atrial flutter procedure with a pentaray nav eco catheter and foreign material and electrode damage was discovered on the catheter.The pentaray was used to create the fast anatomical map and to collect points.The pentaray was used through an agilis sheath, and was swapped out for the smarttouch catheter twice.After the last map was created, the fellow took the pentaray out of the patient¿s body, to replace with the smarttouch, and noticed that there was a translucent, string-like piece attached to one of the pentaray spines.He accidentally dislodged the string from the spline.The spine also appeared bent onward the distal tip.In addition, one of the electrodes on the spline appeared bent as well.This event is mdr reportable because if a foreign material is found adhered to the catheter within the usable length during or after the procedure, this poses a potential risk to the patient.The bent spine is not mdr reportable, however, if the electrode ring appears to be sharp, this also poses a potential risk to the patient.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 03/06/2018.The analysis has begun but is not completed at this time.It was discovered that the edge of electrode #10 is lifted and sharp edges are formed.This finding coincides with the reported event and is mdr reportable, because if the electrode is dented, lifted or ring edges appear to be sharp or rough, this may pose a potential risk to the patient.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atypical atrial flutter procedure with a pentaray nav eco catheter and foreign material and electrode damage was discovered on the catheter.The catheter was visually inspected and electrode # 10 was found to be lifted and a sharp edge was observed.However, no foreign material was found.The catheter outer diameter was measured and it was found within specification.The device history record (dhr) was reviewed.No anomalies were found related to this complaint.Additionally, 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 electrode damage cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures.Manufacturer's ref.No: (b)(4).

• Brand Name: PENTARAY NAV ECO
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7244648
• MDR Text Key: 99614352
• Report Number: 2029046-2018-01155
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2020
• Device Catalogue Number: D128211
• Device Lot Number: 17748218L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Date Manufacturer Received: 01/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1