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

Model Number D128208

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 11/10/2020

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent a cardiac ablation procedure for paroxysmal atrial fibrillation (afib) with a pentaray nav high-density mapping eco catheter and an open package seal issue occurred.It was reported that the inner sterile pouch of the pentaray nav high-density mapping eco catheter had an open corner that wasn¿t completely sealed, and the physician decided to not use the product on the patient.The catheter was replaced, and the procedure continued.No patient consequences were reported.

Manufacturer Narrative

It was reported that the inner sterile pouch of the pentaray nav high-density mapping eco catheter had an open corner that wasn¿t completely sealed, and the physician decided to not use the product on the patient.The catheter was replaced, and the procedure continued.No patient consequences were reported.Device evaluation details: on 12/18/2020, the bwi product analysis lab received the complaint device for evaluation and the evaluation has been completed.The device evaluation has been completed.Upon receipt, the catheter was visually inspected and it was found in normal conditions.Then per the reported event, no test performed since original packaging was not returned for analysis.The customer complaint cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: 10960581
• MDR Text Key: 247899386
• Report Number: 2029046-2020-01885
• 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
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2023
• Device Model Number: D128208
• Device Catalogue Number: D128208
• Device Lot Number: 30437861L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PENTARAY NAV ECO 7FR, F, 2-6-2