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

Model Number SER14-150-20-100

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2024

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 335432399
• Report Number: 3005994106-2024-00001
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1