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

Catalog Number D128208

Device Problems Coagulation in Device or Device Ingredient (1096); Inability to Irrigate (1337); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2018

Event Type  malfunction  

Manufacturer Narrative

Still pending is the manufactured date and the expiration date.Therefore, a supplemental report will be submitted to update the expiration date and manufactured date.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a pentaray nav high-density mapping eco catheter.It was reported the catheter was connected to the flush drip and there was no fluid coming out of the pentaray nav high-density mapping eco catheter tip.It seemed like something was clogging the tip.When the catheter was replaced, the issue resolved.The response received confirmed that the catheter irrigation was occluded due to a failure of the irrigation mechanism and not due to a foreign material.It also confirms that coagulum was noticed on the tip of the catheter.The patient did not exhibit any neurological symptom since the procedure was completed.The system did not present any error messages.They were not ablating.They were using heparin.The irrigation issue was assessed as not reportable.Occlusion or no irrigation is highly detectable by the physician.The potential that it could cause or contribute to a death, serious injury, or other significant adverse event was remote.The coagulum was assessed as a reportable issue.

Manufacturer Narrative

Correction to the 3500 initial report as device code was left blank.Therefore, device code has been populated.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The device history record, manufactured date and expiration date have been provided.Therefore, expiration date and device manufacture date have been populated.The device history record (dhr) for the lot number 30050079l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.No device was received for analysis.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.Therefore, reason for non- evaluation has been updated to other and methods codes, results codes and conclusion codes have been populated.Manufacturer's ref.No: (b)(4).

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7676601
• MDR Text Key: 113911460
• Report Number: 2029046-2018-01782
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012224
• UDI-Public: 10846835012224
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2021
• Device Catalogue Number: D128208
• Device Lot Number: 30050079L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1