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

Model Number D128211

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2020

Event Type  malfunction  

Manufacturer Narrative

On (b)(4) 2020, the biosense webster, inc.Product analysis lab identified the reported issues with the complaint device.The product investigation was subsequently completed.Device evaluation details: upon receipt, the catheter was visually inspected, and it was found the spline bent and electrode lifted.A manufacturing record evaluation was performed for the finished device 30351871l number, and no internal action was found during the review.The root cause of the damage on spline and electrode cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures.The complaint device damage could be related to the handling of the device during the procedure, however, this cannot be conclusively determined.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

A patient underwent an ablation procedure with a pentaray nav high-density mapping catheter for which biosense webster¿s product analysis lab identified that one of the splines was bent with a lifted electrode.It was reported during a atrial fibrillation (afib) cardiac ablation procedure, the tip of the catheter was bent when inserting through the sheath.The catheter was replaced and the issue resolved.No patient consequences were reported.The slightly bent spline is not an mdr-reportable issue.However, the lifted electrode is an mdr-reportable issue.

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10782213
• MDR Text Key: 214788415
• Report Number: 2029046-2020-01621
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• 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
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2023
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30351871L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Date Manufacturer Received: 10/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2020
• 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