MAUDE Adverse Event Report: CREAGH MEDICAL ADVANCE SERENITY 014; PTA CATHETER

Model Number	SER14-120-20-60
Medical Device Problem Codes	Difficult to Remove (1528); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report states the balloon got stuck on the wire guide after deflation.The balloon and wire had to be pulled out.Due to this, the procedure was delayed while the physician obtained a new wire.No patient harm was reported.The device is being returned to manufacturer for evaluation.
Event or Problem Description
Report account indicates the balloon got stuck on the wire and was difficult to remove.This could have caused the balloon to fragment.In this case the physician did require additional intervention, causing procedural delay.No patient harm reported during this event.
Event or Problem Description
Follow up report for mfr report #: to include updated information such as investigation type and conclusion.
Additional Manufacturer Narrative
The device was not returned for evaluation.The results of the investigation have been deemed inconclusive.

• Brand Name: ADVANCE SERENITY 014
• Common Device Name: PTA CATHETER
• Manufacturer (Section D): CREAGH MEDICAL; ida business park; creagh road; ballinasloe, co. galway, ireland ; EI
• Manufacturer (Section G): CREAGH MEDICAL; ida business park; creagh road; ballinasloe, co. galway, ireland ; EI
• Manufacturer Contact: holly ramirez ; 7905 golden triangle drive; eden prairie, MN 55344
• MDR Report Key: 15259042
• Report Number: 3005994106-2022-00004
• Device Sequence Number: 6720559
• Product Code: LIT
• UDI-Device Identifier: 05391525784397
• UDI-Public: 05391525784397
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171251
• 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,Followup
• Report Date (Section B): 09/28/2022

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 Expiration Date: 03/17/2023
• Device Model Number: SER14-120-20-60
• Device Lot Number: 22000664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2020
• 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: Other
• Patient Sex: Unknown