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

Model Number D128208

Device Problems Material Deformation (2976); Material Twisted/Bent (2981)

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

Event Date 05/01/2022

Event Type  malfunction  

Manufacturer Narrative

The product investigation was completed.Device evaluation details: a picture showing catheter packaging and device tip was received for analysis, the photo does not provide sufficient information related to the reported event and therefore no result can be obtained from it.Visual analysis of the returned device revealed that the spline b was found bent, the electrode was found lifted, and no residues of pu (polyurethane) on the edge were observed the instructions for use contain the following recommendations: do not use excessive force to advance or withdraw the catheter through the guiding sheath when resistance is encountered.A manufacturing record evaluation was performed for the finished device 30693822l number, and no internal action was found during the review.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 eco for which biosense webster¿s product analysis lab identified that spline b was found bent, the electrode was found lifted, and no residues of pu (polyurethane) on the edge were observed.The finding was identified on (b)(6) 2022.It was initially reported by the customer that during the procedure electrode 11 was physically damaged and the spline c was partially folded.The physician acknowledged that he pushed with intensity during the introduction into the long sheath.No patient consequences were reported.Bent spline is not mdr-reportable.Electrode damage is mdr-reportable.

• Brand Name: PENTARAY NAV ECO
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15273388
• MDR Text Key: 305498840
• Report Number: 2029046-2022-01956
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012224
• UDI-Public: 10846835012224
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/22/2022

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 Model Number: D128208
• Device Catalogue Number: D128208
• Device Lot Number: 30693822L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2022
• Initial Date Manufacturer Received: 07/29/2022
• Initial Date FDA Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2021
• 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