MAUDE Adverse Event Report: BALT USA BARRICADE COIL SYSTEM

Model Number 900107

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 08/19/2021

Event Type  malfunction  

Event Description

It was reported that: "at the moment of opening the box containing barricade coil 2x4 the bag was apart from the sheath which usually contains the coil, meaning that the coil wasn't sterile.However, the product was removed from its case because it was an emergency and there were no more of these products at that time.When the coil was introduced intro the patient, the x-rays showed that there was no coil, only the carrier wire was present.As one usually advances the coil until it is seen in the x-rays, as there was none, it was pushed and the carrier wire collided with the aneurysm but it didn't rupture it." incident report form received for this complaint indicated no patient injury was sustained.

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 complaint 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.The returned device was inspected in our quality laboratory.During our analysis: - we noted that the returned device pouch was opened and found no abnormalities along the pouch seal; - we observed no puncture holes throughout the pouch; - we observed that the proximal end of the implant still found connected to the delivery pusher; - we observed the implant coil to be broken off of the proximal end of the implant less than 1mm from the glue bond.Root cause of the reported issues endured by the coil system can not be definitively determined.Upon return of this device, it was observed that the pouch was already opened.Further investigation showed that there were no visible abnormalities along the pouch seal, indicating proper closure of the aforementioned pouch.Moreover, no puncture holes were seen throughout the pouch.Despite sterility issue claims, the device was used which contradicts the ifu statement "the bcs is intended for single use only.Do not resterilize and/or reuse the device.Reuse of the device may result in re-infection or cross-infection.After use, dispose in accordance with hospital, administrative and/or local government policy.Do not use if the packaging is breached or damaged." it was then noted that "when the coil was introduced intro the patient, the x-rays showed that there was no coil, only the carrier wire was present.As one usually advances the coil until it is seen in the x-rays, as there was none, it was pushed and the carrier wire collided with the aneurysm but it didn't rupture it." additional investigation showed that the proximal end of the implant was still found connected to the delivery pusher, indicating that a coil was previously attached to the pusher system.Per lhr, 100% inspection was conducted, with qc final inspection and pouch inspection approval.It is unknown how or when the implant coil separated from its respective pusher system.It is possible that the implant became fractured from the delivery pusher while the coil system was being removed from the pouch, but this cannot be confirmed.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 f200100198 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: BARRICADE COIL SYSTEM
• Type of Device: BARRICADE
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• Manufacturer Contact: david vu ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 17572780
• MDR Text Key: 321640412
• Report Number: 3014162263-2023-00031
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00818053021060
• UDI-Public: (01)00818053021060(11)200131(17)250131(10)F200100198
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K151760
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900107
• Device Lot Number: F200100198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2020
• 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