MAUDE Adverse Event Report: BALT USA ECLIPSE2L BALLOON CATHETER

Model Number	ECL2L6X15
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa reference # (b)(4).Note: this complaint file is being reported late as part of a corrective action following an fda inspection.After a review of historical complaint files, it was determined that for this compaint the device failed to meet its performance specifications according to the initial claim submitted by the user.For these complaints, the potential harm did not lead to a serious injury or death, however the performance specification which was failed to be met for these complaints could have led to a serious injury or death based on the initial information that was reported to balt.Investigation of the reported issue is ongoing at the time of this report.The submission of this report or related information to the fda, and its release by fda, does not reflect a conclusion by the party submitting this report of the fda that the report or related information is an admission that the manufacturer, their employees, or the device caused or contributed to the reportable event.
Event or Problem Description
It was reported that: "during an embolization procedure, an ecl2l6x15 was used without incident.However, upon my inspection of the box for the ifu, i determined that a magic ifu was inside the box and not an eclipse ifu.I saved the box and magic ifu and hand delivered to balt qa.There are two more ecl2l6x15 on the shelf at (b)(6), with the same lot number.I did not want to compromise the label and tape that secure the packaging but suspect that these two units also might also have a magic ifu inside and not an eclipse ifu.If it is determined that the issue may extend beyond this one unit and/or if the two units on the shelf can aid in the investigation to determine if the entire lot is effected, please provide an ra for the units and replacements delivered to my home address for swap.".
Additional Manufacturer Narrative
Balt usa reference (b)(4).On october 3, 2022, an embolization procedure was performed and an ecl2l6x15 (lot number: f220300837) was used without incident.However, upon the sale's representative inspection of the box for the ifu, it was determined that a magic ifu (r210100024) was inside the box, and not an eclipse ifu.Hhe-015 has been issued for this matter and identified to close work orders operators must allocate parts to the work order.If the operator inputs a part number that is not in the bom of the unit being built, then the erp system will not let the operator move on.According to sop0048: work order procedure, production personnel should, "notify supervisor if any operation is open or the requirements are not met." when closing out wo030521, the operator noticed the lot number in the ifu section was for a magic ifu rather than an eclipse2l ifu.The operator asked the lead on duty what he should do, and the lead instructed the operator to cross out the magic ifu lot number and replace it with an eclipse2l lot number, attributing the error to a mistake.The operator made the changes to the lhr and closed out the work order without verifying the ifu in the carton.The risk is minor as this is not a product functionality issue.The risk is also improbable.There are a total of three lots that were implicated with the discrepancy of a magic ifu in an eclipse2l unit.The three lots are lot #f220300836, lot #f220300837, and lot #f220300838.As of 16mar2023, all three lots have expired.The three lots are implicated under hhe-015, however because the units are already expired, no action is required.Further corrective action is being taken under the capa-p-1060.Review of the lot history records did not reveal any in-process or lot-specific issue that could account for the observation.No additional complaints against lot number f220300837 has been made for the same issue.Comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.The submission of this report or related information to the fda, and its release by fda, does not reflect a conclusion by the party submitting this report of the fda that the report or related information is an admission that the manufacturer, their employees, or the device caused or contributed to the reportable event.
Event or Problem Description
It was reported that: "during an embolization procedure, an ecl2l6x15 was used without incident.However, upon my inspection of the box for the ifu, i determined that a magic ifu was inside the box and not an eclipse ifu.I saved the box and magic ifu and hand delivered to balt qa.There are two more ecl2l6x15 on the shelf at ucla with the same lot number.I did not want to compromise the label and tape that secure the packaging but suspect that these two units also might also have a magic ifu inside and not an eclipse ifu.If it is determined that the issue may extend beyond this one unit and/or if the two units on the shelf can aid in the investigation to determine if the entire lot is effected, please provide an ra for the units and replacements delivered to my home address for swap." incident report form submitted for this complaint indicates that no patient injury was sustained.

• Brand Name: ECLIPSE2L BALLOON CATHETER
• Common Device Name: ECLIPSE2L
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• Manufacturer Contact: david vu ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 17484705
• Report Number: 3014162263-2023-00028
• Device Sequence Number: 7246463
• Product Code: MJN
• UDI-Device Identifier: 00818053022982
• UDI-Public: (01)00818053022982(11)220316(17)230316(10)F220300837
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K183045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/16/2023
• Device Model Number: ECL2L6X15
• Device Lot Number: F220300837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2023
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown