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

Model Number	SER14-150-20-100
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The site reported they used two balloons in a percutaneous transluminal angioplasty (pta) procedure of the anterior tibial artery.Each balloon was reported to rupture on initial inflation.The balloons were prepared per ifu and used in coordination with an 0.014" guidewire and 6f sheath.The degree of stenosis in the target vessel was severe.Both balloons ruptured during initial inflation.The procedure was successfully with a competitors device.Good distal flow was ultimately established.No further medical intervention was required.There was not patient harm.
Additional Manufacturer Narrative
H3: device analysis of both balloons confirmed the reported issue.During inflation testing with water, fluid leakage was observed through a pin hole at the distal marker band region on both balloons.

• 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 ; 9525077598
• MDR Report Key: 18673151
• Report Number: 3005994106-2024-00001
• Device Sequence Number: 15302629
• Product Code: LIT
• UDI-Device Identifier: 05391525784762
• UDI-Public: 05391525784762
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/08/2024

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: SER14-150-20-100
• Device Lot Number: 22301728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2023
• 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
• Patient Sex: Unknown