MAUDE Adverse Event Report: BALT USA PRESTIGE COIL SYSTEM

Model Number	PRES0520HPKPL
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "dr.(b)(6) was treating a bleed at the gda origin.After advancing 4 prestige plus coils successful she went to advance a pres0520hpkpl coil but it wasn't forming the way she wanted.She then thought she resheathed the coil and did a contrast run.Once she did the run she noticed the coil fly out of the microcatheter and go in the hepatic artery, thus the prestige plus 5x20cm was prematurely detached.They successfully recaptured the coil with a snare and completed the case.".
Additional Manufacturer Narrative
(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.Dhr cannot be reviewed as the lot number of the reported unit was not reported.

• Brand Name: PRESTIGE COIL SYSTEM
• Common Device Name: PRESTIGE
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• MDR Report Key: 12623769
• Report Number: 3014162263-2021-00034
• Device Sequence Number: 14583405
• Product Code: HCG
• UDI-Device Identifier: 00818053027192
• UDI-Public: 00818053027192
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/07/2021

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: PRES0520HPKPL
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 10/13/2021
• 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: Required Intervention