MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0413CSF10
Medical Device Problem Codes	Stretched (1601); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa's reference number: (b)(4).An evaluation of the actual complaint sample could not be performed as the device was unavailable for 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 f220200781 has been made for the same issue.Comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.
Event or Problem Description
It was reported that: "optima coil 4-13 was used to treat ica wideneck aneurysm.While deploying the coil to fill the aneurysm, coil was not properly filling in the aneurysm.After giving multiple attempts, coil seems to got damaged (stretched).It got prematurely detached inside and got completely stretched.Could not retrieve back the stretched part.Kindly consider this as a product failure." update 29apr2022 - additional information received from the issuer: "·can you explain where the coil prematurely detached? was it inside the microcatheter or outside? · prematurely detached inside microcatheter, coil was half deployed and half inside microcatheter.·what happened with the stretched coil that was unable to be retrieved? · coil got stretched completely, it became like thread.Half coil was inside aneurysm and rest stretched thread had to cut from groin.·to confirm, was any harm endured by the patient? no harm was endured by the patient.".

• Brand Name: OPTIMA COIL SYSTEM
• Common Device Name: OPTIMA
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• Manufacturer Contact: moises colin ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 14466347
• Report Number: 3014162263-2022-00015
• Device Sequence Number: 4686208
• Product Code: HCG
• UDI-Device Identifier: 00818053026119
• UDI-Public: 00818053026119
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K172390
• 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): 05/17/2022

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: OPTI0413CSF10
• Device Catalogue Number: N/A
• Device Lot Number: F220200781
• 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: 04/27/2022
• Initial Report FDA Received Date: 05/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2022
• 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