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

Model Number D128211

Device Problems Device-Device Incompatibility (2919); Sharp Edges (4013)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2021

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 04-sep-2021.The device evaluation was completed on (b)(6) 2021.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection, and outer diameter (od) test of the returned product.Visual analysis of the returned sample revealed electrodes lifted -crushed on spines, this condition could be related to handling of the device during the procedure; however, this cannot be conclusively determined.The od test failed due this condition.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device 30534287l number, and no internal action was found during the review.Instructions for use states the following recommendation to avoid resistance or friction issues: -the pentaray¿ nav eco catheter is recommended for use with an 8f guiding sheath.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

It was reported that a patient underwent an atrial flutter (afl) procedure with a pentaray nav high-density mapping eco catheter and the biosense webster, inc.Product analysis lab observed electrodes lifted crushed on spine issue.Initially it was reported that the pentaray nav high-density mapping eco catheter would not pass through the vizigo sheath.The smarttouch catheter passed through with no issues.There was no patient consequence reported.The issue with the pentaray nav high-density mapping eco catheter was assessed as not mdr reportable for an impeded device issue.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on (b)(6) 2021 electrodes lifted crushed on spine were observed.The electrodes lifted crushed on spine was assessed as mdr reportable.The awareness date for this reportable lab finding was (b)(6) 2021.

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12637117
• MDR Text Key: 281991674
• Report Number: 2029046-2021-01747
• 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
• Type of Report: Initial
• Report Date: 10/14/2021

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: 03/10/2024
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30534287L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2021
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8.5F SHEATH WITH CURVE VIZ MDC; PENTARAY NAV ECO 7FR, D, 2-6-2; SMARTTOUCH CATHETER