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

Model Number	SER18-90-50-80
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The balloon was used during an femoropopliteal angioplasty procedure.The site reported the balloon fragmented and appeared to left fragments in the patient.Additional information indicated approximately half of the balloon detached inside the patient.The patient had an additional procedure the next day to remove the balloon fragment.There was no further impact to the patient.
Additional Manufacturer Narrative
H3: to date, the device had not been returned.If returned, a supplemental mdr will be submitted for analysis results.
Event or Problem Description
Additional information received from the distributor indicated the device was used in a right femoropopliteal below knee anastomosis angioplasty procedure (left retrograde approach).The target lesion was approximately 3cm in length with severe stenosis.The issue occurred following the use of a competitor 4mm balloon.The 5mm balloon was used due to persistent stenosis and used for one inflation.The balloon reportedly did not burst fully and still required a syringe to fully deflate.The balloon then detached from the catheter during removal.The remaining segment required hospital admission, heparin infusion, and surgical removal the next day.The patient was recovering post removal, redo of the proximal anastomosis, and percutaneous femoral artery endarterectomy.
Event or Problem Description
Additional information received from the site via the distributor indicated during balloon removal, the inner component appeared to adhere to the 0.018" guidewire and only one marker band was left on the balloon.It was unknown if the other marker band also adhered to the guidewire.
Additional Manufacturer Narrative
H3: analysis confirmed the reported issue.The balloon was returned in three segments.Segment one contained the main body of the device to include the manifold, strain relief, outer shaft, and a portion of the balloon.The second segment contained a portion of the inner shaft and the proximal marker band.The third segment was the distal portion of the balloon and device tip.Approximately 32cm of the inner shaft and distal marker band were missing.The site indicted the inner shaft adhered to the guidewire upon removal and the marker band may have also remained on the wire.A hole was observed in the third balloon segment, approximately 4cm from the distal tip and approximately 0.75cm from the proximal to the point of balloon separation.

• 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: 18074449
• Report Number: 3005994106-2023-00010
• Device Sequence Number: 7759666
• Product Code: LIT
• UDI-Device Identifier: 05391525786704
• UDI-Public: 05391525786704
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/26/2026
• Device Model Number: SER18-90-50-80
• Device Lot Number: 22202854
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2023
• Supplement Date Received by Manufacturer: 11/30/2023; 12/13/2023
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 12/11/2023; 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 70 KG