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 Device Issue (2379); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

Concomitant product: lasso catheter, us catalog #: unknown, lot #: unknown.Pentaray nav high-density mapping eco catheter, us catalog #: d128208, lot #: 17731231l.Non ¿ biosense webster, inc.- agilis 8.5 f sheath.Investigation summary: the returned device was visually inspected and during the first visual inspection the catheter was found in normal conditions, however, crushed rings with sharp edges and foreign material were found during the second visual inspection.Then, the catheter outer diameter was measured and it was found within specifications.Per the condition observed, a scanning electron microscope (sem) testing was performed and the results showed evidence of mechanical damage on the surface of the ring and a sharp edge was found.It is possible that the damage was generated with an unknown object.In addition, a fourier transform infrared spectroscopy (ft-ir) was performed to identify the type of foreign material and the results showed that foreign material is presumably composed of styrene based material, presumably the copolymer known as abs, this polymer is widely use along medical device industries.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.During manufacturing process, all the catheters are inspected for visual damages before packaging.On line inspections and functional tests are in place to prevent this type of damage from leaving the facility.The customer complaint was not confirmed.Based on available analysis finding results, the damage observed and the foreign material does not appear to be caused by any internal biosense webster, inc.Processes.It could be related to the handling of the product since there is evidence that the device was manufactured in accordance with documented specification and procedures.(b)(4).

Event Description

It was reported that a patient underwent an atrial tachycardia left (l-at) procedure with a pentaray nav high-density mapping eco catheter.The pentaray nav high-density mapping eco catheter would not introduce into the 8.5f agilis sheath through the introducer.The caller tried a second catheter without resolution.A lasso catheter was substituted and the issue was resolved.The procedure was continued.There was no patient consequence reported.This reported issue was assessed as not reportable.Interference or friction between devices is a known occurrence.If resistance is encountered, the system may be withdrawn as a unit.This is a common practice during procedures.Since the vast majority of ep procedures utilize multiple device exchanges, an increased potential for patient injury is remote.The biosense webster failure analysis lab received the device for evaluation and discovered during the assessment on january 29, 2018 that the electrode rings were crushed with sharp edges and had foreign material.The electrode rings having sharp edges with the foreign material have been assessed as a reportable malfunction.

• 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
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 7286244
• MDR Text Key: 100904503
• Report Number: 2029046-2018-01239
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012224
• UDI-Public: 10846835012224
• 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: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2020
• Device Catalogue Number: D128208
• Device Lot Number: 17731231L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Date Manufacturer Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2017
• 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