MAUDE Adverse Event Report: BALT USA PRESTIGE COIL SYSTEM

Model Number	PRES0410CPKPLT
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the physician decided to use a truselect 2.0f microcatheter to coil the outflow of a renal aneurysm.She selected a 4x10 prestige plus coil from the jackson consignment.The sheath came off the coil and she began advancing when she felt resistance, she pushed through slightly and the coil seemed to loop as if the front end was stuck and the back end was still attached to the pusher coil.The coil then broke off but the tread part of the 4x10 stayed lodged in the microcatheter.This led to pre detachment and need for completely new access.After replacing the microcatheter, she snared the rest of the coil out of the vessel and proceeded to use penumbra (8 coils) for the remainder of the case." incident report form submitted for this complaint indicates that no patient injury was sustained.
Additional Manufacturer Narrative
Balt usa reference#: (b)(4).An evaluation of the actual complaint sample could not be performed as device was unavailable to be return.Based on the provided information, root cause could not be definitively determined.Lack of device return prevented deeper evaluation of the reported issue.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: f230700337 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.

• Brand Name: PRESTIGE COIL SYSTEM
• Common Device Name: PRESTIGE
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• Manufacturer Contact: david vu ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 20588447
• Report Number: 3014162263-2024-00088
• Device Sequence Number: 8943344
• Product Code: KRD
• UDI-Device Identifier: 00810068567465
• UDI-Public: (01)00810068567465(11)230714(17)280714(10)F230700337
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K200030
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/01/2024

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 Model Number: PRES0410CPKPLT
• Device Lot Number: F230700337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown