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 Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)

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

Event Date 05/11/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an unspecified ablation procedure with a pentaray nav high-density mapping eco catheter and upon receipt of the shipment with the catheter inside the box appeared to be smashed and the inner packaging looks disrupted.The medical team suspected that the device could've possibly been contaminated due to the packaging issues.The device was not used on the patient.No patient consequences were reported.Damaged packaging (box) is not mdr-reportable.Open pouch seal is mdr-reportable.

Manufacturer Narrative

The bwi product analysis lab received photographs of the complaint device's outer and inner packaging for evaluation.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc.Or its employees caused or contributed to the potential event described in this report.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 reference number:(b)(4).

Manufacturer Narrative

On (b)(6) 2023, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.The photo analysis was completed as well.It was reported that a patient underwent an unspecified ablation procedure with a pentaray nav high-density mapping eco catheter and upon receipt of the shipment with the catheter inside the box appeared to be smashed and the inner packaging looks disrupted.The medical team suspected that the device could've possibly been contaminated due to the packaging issues.The device was not used on the patient.No patient consequences were reported.Device evaluation details: a picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, the box of the catheter was observed damaged, the damage observed on the box could be related to the distribution process; however, this cannot be conclusively determined.The device was returned to biosense webster (bwi) for evaluation.A visual inspection of the returned device was performed following bwi procedures.Visual analysis revealed damage in the packaging, it was observed broken.The damage could be related to the process of storing, packaging or shipping of the device, however, this cannot be conclusively determined.In the other hand, according to the provided pictures by the customer, it look like that the pouch is open however, during a visual inspection in detail, no damage were observed, the pouch is seal without any damage.A manufacturing record evaluation was performed for the finished device number lot 31005658l and no internal action related to the complaint was found during the review.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17080405
• MDR Text Key: 316770573
• Report Number: 2029046-2023-01246
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/11/2023

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: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 31005658L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2023
• Initial Date FDA Received: 06/07/2023
• Supplement Dates Manufacturer Received: 06/14/2023
• Supplement Dates FDA Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2023
• 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