MAUDE Adverse Event Report: BALT USA PRESTIGE COIL SYSTEM

Model Number	PRES0635CPKPLT
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the physician performing a bronchial avm with a renegade 18 microcatheter 150cm with a base 5f diagnostic catheter.Used one prestige 6x15 le coil with no issues and was deployed without issue.Grabbed 1 6x35 prestige le and as the coil advanced he said it was getting harder to push that was right after he stepped on fluro as the fluro save marker passed by.He tried to reposition and said that it looked liked to pre-detached.He grabbed a 1cm syringe to squirt the coil and it appeared it went into the coil mass without issue.He grabbed 1 more 6x35 prestige le and this time as he advanced it would not advance as there was coil from the 1st 6x35 coil in the microcatheter because the coil broke and was in a rats nest of inner coil.He had to lose access and abort the case." update 10jan2024 - additional information received from the issuer: "1.How would the tortuosity be described in this procedure? see attached photos it was very tortuous.2.For complaint (b)(4), are we also receiving this unit? not sure why there are two complaints as it was one case.I am sending back the renegade 18 and the 6x15 pusher and the 6x35 pusher with no coils as they are in the patient's body.The third coil was thrown away and not implanted.3.For complaint (b)(4), could you elaborate by what is meant by "he noticed a piece of coil"? the coil that broke fractured and the inner coil came apart in the patient.You can see it in the photo i sent as well it is very fine and strings out of the coil pack.4.Can you confirm if you were attending the procedure? i was in the procedure and we can discuss live if there are questions." 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: analysis of returned microcatheter: we observed a major kink/ovalization approximately 1cm from the distal tip.We observed a minor kink/ovalization approximately 45cm from the distal tip.We noted after flushing the returned microcatheter during the decontamination process, only residual blood was flushed out.We noted the od of the microcatheter at the major kink measured 0.022in (compared to 0.031in at marker band); we noted when the microcatheter was subjected to a minor curve, friction was felt when advancing an in-house coil system through the major kink.Delivery pusher: we noted that the returned delivery pusher was able to advance out of the in-house introducer sheath.We observed multiple minor kinks along the hypotube.We observed the detachment zone was severely bent including the green lead wire.We noted the sr thread within the body coil was opaque in color.We observed no signs of detachment cycle being ran at the detachment zone.Based on the available information and the investigation results the complaint can be confirmed.Root cause of the reported issue can likely be attributed to an overload of tensile stress being endured by the sr thread, leading to the premature detachment.Upon device return, it was noted that the associated microcatheter and delivery pusher was returned for analysis.The associated introducer sheath and implant coil were not returned as it was indicated the physician was able to implant the coil.During the device analysis, it was noted the returned microcatheter had a major kink/ovalization located approximately 1 cm from the distal tip.At this location, the outside diameter of the microcatheter was measured to be 0.022", compared to the location of the distal marker band measuring 0.031".Due to the damage, the id of the microcatheter could not be accurately measure.Based on the measurement of the outside diameter, it is estimated that the inside diameter measured approximately 0.012" (0.021" original inside diameter - 0.009" od delta = 0.012").An in-house coil system was advanced through the returned microcatheter, for which some friction was felt when the microcatheter was subjected to a slight bend.Based on the reported information, it is possible that the damage sustained by the microcatheter contributed to the reported advancement and premature detachment issue.If the microcatheter becomes temporarily or permanently kinked/ovalized, this can apply additional forces to the implant coil of the coil system, leading to the user experiencing friction.In some cases, if the friction experienced is severe when attempting to manipulate the implant coil, this can cause the implant to become prematurely detached within the microcatheter.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 record for the reported lot was performed.One additional complaint with lot number f240901057 was filed in conjunction with this report; however, there is no in-process or lot-specific issue that could account for the observation.This lot will remain 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: 21334321
• Report Number: 3014162263-2025-00002
• Device Sequence Number: 8550348
• Product Code: KRD
• UDI-Device Identifier: 00810068567564
• UDI-Public: (01)00810068567564(11)240930(17)290930(10)F240901057
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 02/07/2025

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 Model Number: PRES0635CPKPLT
• Device Lot Number: F240901057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2024
• 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