MAUDE Adverse Event Report: BALT USA BARRICADE COIL SYSTEM

Model Number	900087
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To whom it may concern: on (b)(6) 2020, balt usa has been notified of an event regarding the use of a single barricade coil (5mm x 20cm helical fill soft).Details reported as follows: "the case was a cavernous ica wide neck aneurysm measuring 8mmx 7mm and the neck measured 6mm.The physician planned to do a balloon assisted coiling of the aneurysm.The support hardware was 7f cook long sheath followed by 6f fargomax.The copernic 5x20 was taken along with vasco 10mp with hybrid 12/14 guide wire.The first coil was 9x30 complex frame followed by 8x30 helical fill coil.Check angio showed aneurysm still filling and the physician opted to use helical fill 5x20 coil.The balloon was inflated and the coiling was in progress during which the physician felt a snap and saw that the coil had prematurely detached and no movement was there.The physician deflated the balloon and tried to get the vasco along with coil back into the guide.During this process the coil came proximal to guide and only the push wire came out.Some part of the coil was still hanging from the neck of the aneurysm and into the ica.The physician opted to leave the same as it is." the returned device was inspected in our quality laboratory.During our analysis: we noted the return of a used stent, which was not reported as part of the procedure.We observed the detachment zone to be clean and free of any signs of a normal detachment being performed.We observed some adhesive of the detachment zone's distal end to be torn.We observed the sr thread to be clear and not opaque in color, thus meaning a quick snap of the thread took place.Root cause cannot be definitely determined as it is unknown how the implant prematurely detached.It is possible that the implant became entangled with other devices at the treatment site during placement.Review of the lot history record did not reveal any in-process or lot-specific issue that could account for the observation.No additional complaints against lot number f191100210 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: "the case was a cavernous ica wide neck aneurysm measuring 8mmx 7mm and the neck measured 6mm.The physician planned to do a balloon assisted coiling of the aneurysm.The support hardware was 7f cook long sheath followed by 6f fargomax.The copernic 5x20 was taken along with vasco 10mp with hybrid 12/14 guide wire.The first coil was 9x30 complex frame followed by 8x30 helical fill coil.Check angio showed aneurysm still filling and the physician opted to use helical fill 5x20 coil.The balloon was inflated and the coiling was in progress during which the physician felt a snap and saw that the coil had prematurely detached and no movement was there.The physician deflated the balloon and tried to get the vasco along with coil back into the guide.During this process the coil came proximal to guide and only the push wire came out.Some part of the coil was still hanging from the neck of the aneurysm and into the ica.The physician opted to leave the same as it is.".

• Brand Name: BARRICADE COIL SYSTEM
• Common Device Name: BARRICADE
• Manufacturer (Section D): BALT USA; 29 parker; irvine, ca
• MDR Report Key: 10259640
• Report Number: 3014162263-2020-00014
• Device Sequence Number: 19697551
• Product Code: HCG
• UDI-Device Identifier: 00818053020865
• UDI-Public: 00818053020865
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K151760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2020

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: 12/10/2024
• Device Model Number: 900087
• Device Catalogue Number: 900087
• Device Lot Number: F191100210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 07/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other