MAUDE Adverse Event Report: BALT USA PRESTIGE COIL SYSTEM

Model Number	PRES0930HPKPL
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the coil was placed in the vessel and was in place and went to deploy coil and when it detached and was pulled back the filment of the coil came with the pusher wire and it unravled." update 01apr2024 - additional information received from the issuer: "1.Did the procedure involve tortuous anatomy? i don't know 2.Can you confirm if their was patient injury? the patient was taken to have the coil surgically removed.3.Was there physician intervention due to this incident? i don't understand the question 4.How did the procedure conclude? the removed the coil surgically." incident report form submitted for this complaint indicates that no patient injury was sustained.
Additional Manufacturer Narrative
Balt usa reference # (b)(4).Investigation pending return of suspected device.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: "the coil was placed in the vessel and was in place and went to deploy coil and when it detached and was pulled back the filment of the coil came with the pusher wire and it unravled." update 01apr2024 - additional information received from the issuer: "1.Did the procedure involve tortuous anatomy? i don't know.2.Can you confirm if their was patient injury? the patient was taken to have the coil surgically removed.3.Was there physician intervention due to this incident? i don't understand the question.4.How did the procedure conclude? the removed the coil surgically." incident report form submitted for this complaint indicates that no patient injury was sustained.
Additional Manufacturer Narrative
Balt usa reference # (b)(4).The returned device was inspected in our quality laboratory.During our analysis: we observed the introducer sheath was not included with the device return.We observed the sr thread within the implant coil to be opaque in color.We observed that the implant coil is severely stretched through out its length.We observed the detachment zone to be significantly damaged, however the pet jacket.Lead wire solder joints, and sr thread remained intact.We observed multiple minor and major kinks along the hypotube.Root cause of the reported issue cannot definitively be determined; however, it is evident that the implant coil had become stretched.Upon the return of the device, we observed severe stretching along implant coil.In addition, we observed the sr thread within the implant coil to be opaque in color and multiple minor and major kinks along the hypotube.From our observations, it's possible the coil system was damaged from encountering friction and became stretched following attempts to advance and retract the coil system.If the implant coil had become damaged within the microcatheter from encountering friction, this can make it difficult to advance the coil system within the microcatheter and lead to the implant coil becoming stretched upon retracting.Moreover, it is unknown if the microcatheter associated with the incident was damaged, which could have caused friction during advancement attempts and potentially lead to the reported issue.It is indicated in the lhr that the unit underwent 100% inspection which verifies that the implant was free of damage at the point of final inspection.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 f211200316 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: 19192511
• Report Number: 3014162263-2024-00022
• Device Sequence Number: 7620826
• Product Code: KRD
• UDI-Device Identifier: 00818053027239
• UDI-Public: (01)00818053027239(11)211206(17)261206(10)F211200316
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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: PRES0930HPKPL
• Device Lot Number: F211200316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2024
• Supplement Date Received by Manufacturer: 03/29/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2021
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown