MAUDE Adverse Event Report: CREAGH MEDICAL ADVANCE SERENITY¿ 14; Catheter, angioplasty, peripheral, transluminal

Model Number	SER14-120-30-150
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The site reported the balloon ruptured.It was also noted the guidewire stuck to the balloon.It was also noted the balloon had poor navigability.After "de-inflating", the balloon ruptured.The physician also had difficulty removing the guidewire from inside the balloon.Regarding the balloon pressures, the physician "respected the values." no sections of the balloon remained in the patient.The patient did not require any additional procedures.There was no patient harm.
Additional Manufacturer Narrative
H3: to date, the device had not been returned.If returned, a supplemental mdr will be submitted for analysis results.

• Brand Name: ADVANCE SERENITY¿ 14
• Common Device Name: Catheter, angioplasty, peripheral, transluminal
• Manufacturer (Section D): CREAGH MEDICAL; ida business park; creagh road; ballinasloe, co. galway H53 K 8P4; EI H53 K8P4
• Manufacturer (Section G): CREAGH MEDICAL; ida business park; creagh road; ballinasloe, co. galway H53 K 8P4; EI H53 K8P4
• Manufacturer Contact: phil haney ; 7905 golden triangle drive; suite 190; eden prairie, MN 55344 ; 9525007598
• MDR Report Key: 18042936
• Report Number: 3005994106-2023-00009
• Device Sequence Number: 8077244
• Product Code: LIT
• UDI-Device Identifier: 05391525784564
• UDI-Public: 05391525784564
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K171251
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2023

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: 12/05/2024
• Device Model Number: SER14-120-30-150
• Device Lot Number: 22102926
• 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: 10/03/2023
• Initial Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown