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 Material Separation (1562); Sharp Edges (4013)

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

Event Date 11/09/2021

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter and a material separation occurred.It was reported that during the afib surgery when catheter was inserted into the atrial and passed though introducer, physician observed that electrode fell off into the introducer.Immediately removed the device and changed another one to complete the surgery.There was no patient consequence.

Manufacturer Narrative

The product has not returned for analysis, however, a picture was provided by the customer.Evaluation is still in progress.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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.(b)(4).

Manufacturer Narrative

On 9-dec-2021, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter and a material separation occurred.It was reported that during the afib surgery when catheter was inserted into the atrial and passed though introducer, physician observed that electrode fell off into the introducer.Immediately removed the device and changed another one to complete the surgery.There was no patient consequence.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation and the evaluation has been completed.Bwi conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that a spine was observed bent and stretched; also, the rings #9 and #10 were missing.Rings #11 and #12 were separated, and no pu was observed on edge.The damage could have been forced by inserting them into the sheath.The identified damage on the rings is considered to be an mdr reportable malfunction since ring edges might be sharp.The unit was inspected before leaving the facility.There are functional tests and inspections at control points based on the process flow diagram of this device per its part number that indicates proper manufacturing according to documented specifications and procedures.A manufacturing record evaluation was performed for the finished batch number, and no internal actions were identified.All devices are manufactured, inspected, and released to approved specifications as part of bwi's quality process.It should be noted that product failure is multifactorial.The instructions for use contain the following precautions in the instructions for use: this catheter is recommended for use with an 8f guiding sheath as the distal spines may be damaged if used with a sheath that is not compatible and is recommended to collapse the spines together before insertion and avoid bending the spines.It was reported that during surgery of af, when the catheter was inserted into the atrial and passed through the introducer, the physician observed that electrode fell off into the introducer, immediately removed the device, and changed another one to complete the surgery.In addition to pictures were provided by the customer to aid in the investigation.The pictures showed one of the splines damaged and some electrodes were squashed/missing.The customer complaint was also confirmed based on the picture received.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; 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12930357
• MDR Text Key: 283266119
• Report Number: 2029046-2021-02109
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30619766L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2021
• 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
• Treatment: PENTARAY NAV ECO 7FR, D, 2-6-2; UNKNOWN SHEATH