MAUDE Adverse Event Report: BALT USA PRESTIGE COIL SYSTEM

Model Number	PRES1655COM18
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa's internal reference # (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.
Event or Problem Description
It was reported that: "the physician was utilizing a boston scientific truselect mc and was coiling off a splenic artery aneurysm.He started off with a 22mm prestige, followed by 2- 22mm and 1-18mm.He then went to palce a 16x55 prestige plus com 18 coil and it wasn't forming properly.After trying to remove it he noticed it pre-maturely detached inside the aneurysm and splenic artery.He then snared the coil out successfully and used two more prestige coils.".

• Brand Name: PRESTIGE COIL SYSTEM
• Common Device Name: PRESTIGE
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• MDR Report Key: 12720520
• Report Number: 3014162263-2021-00037
• Device Sequence Number: 19987004
• Product Code: HCG
• UDI-Device Identifier: 00818053023262
• UDI-Public: 00818053023262
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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): 10/26/2021

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: PRES1655COM18
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 10/29/2021
• 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