MAUDE Adverse Event Report: BIOSENSE WEBSTER INC LASSO® NAV ECO CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Model Number D134901

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

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

Event Date 01/14/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a lasso® nav eco catheter and there was damage to the interior packaging of the product and sterility was compromised.It was reported by physician that the sterilization package was broken and product was dirty.So they didn¿t use the catheter in/on patient; they replaced it with a new one.There was no patient consequence.

Manufacturer Narrative

Device investigation details: the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.The package was disposed of because the patient had an infectious disease.As such, the packaging and the product cannot be shipped back.A manufacturing record evaluation was performed for the finished device 30540453l number, and no internal actions related to the complaint 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 ref.# (b)(4).

• Brand Name: LASSO® NAV ECO CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• 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: 13507333
• MDR Text Key: 289007224
• Report Number: 2029046-2022-00261
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835009651
• UDI-Public: 10846835009651
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K113213
• 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
• Report Date: 02/10/2022

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 Expiration Date: 04/04/2024
• Device Model Number: D134901
• Device Catalogue Number: D134901
• Device Lot Number: 30540453L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/14/2022
• Initial Date FDA Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2021
• 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: 7FR DEF LASSONAV SH,12P,15MM,D