MAUDE Adverse Event Report: CREAGH MEDICAL ADVANCE SERENITY¿ 18; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	SER18-150-40-150
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: analysis confirmed balloon damage.The balloon catheter was returned in several segments.The distal tip of the balloon along with the distal marker band, along with approximately 800mm of the inner shaft were not returned.The missing components were believed to be stuck to the guidewire.The guidewire was not returned.
Event or Problem Description
The balloon catheter was used during a percutaneous transluminal angioplasty (pta) procedure.The site inflated the balloon into the interior and exterior iliac artery.It was noted the internal and external iliac arteries were heavily calcified.When deflating, the balloon ruptured.The balloon catheter was individually removed, but pieces of the balloon stayed on the wire.The site was able to capture the remaining pieces with the catheter.The process resulted in approximately one hour procedure delay.There was no patient harm.
Event or Problem Description
Additional information received from the distributor indicated the device was prepped per ifu.There was no indication damage during device preparation.The site denied torquing or twisting device during loading to the target lesion.Vessel calcification was noted to be high with an approximate lesion length of 150mm.The degree of stenosis was reported to be a complete total occlusion (cto).The number of total device inflations and if device movement was required between inflations were unknown.The procedure was considered successful.It was noted that more endovascular work was required, but there was no surgical intervention.The patient was successfully discharged.The balloon was used to create a track.Once access was obtained and the lesion was crossed, a drug coated balloon (dcb) was used.The missing segments of the balloon were unable to be retained for return analysis.

• Brand Name: ADVANCE SERENITY¿ 18
• 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: 19779023
• Report Number: 3005994106-2024-00010
• Device Sequence Number: 12770197
• Product Code: LIT
• UDI-Device Identifier: 05391525784359
• UDI-Public: 05391525784359
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K180007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: SER18-150-40-150
• Device Lot Number: 22400479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2024
• 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 Age: 59 YR
• Patient Sex: Male
• Patient Weight: 91 KG