MAUDE Adverse Event Report: SABER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48005020X
Medical Device Problem Codes	Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b5, d4, g3, h1, h2, h3 and h6.A review of the manufacturing documentation associated with lot 82246696 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, 5mm 20cm saber.018 was put in a heavily calcified artery that was treated with a non-cordis rotablator.Upon second inflation, the balloon ruptured on the calcium.The atms are unknown.The balloon was then being removed over a wire when it may have got caught on calcium.When balloon was pulled out, the scrub tech noticed the distal part of balloon was still in the sfa.The balloon fragment was not removed from the vessel, it was stented across.The patient was taken to the hospital and surgery was done because the patient¿s vessel had thrombosed after.It is believed to be due to some of the balloon fragment still sticking in sfa and partially occluding and slowing the flow.It is unknown what was done during surgery; however, the patient is currently doing well and her sfa is open and has blood flow.The balloon was stored properly according to the ifu and it was prepped correctly as well.The patient was known to have heavily calcified arteries.The device will be returned for evaluation.

• Brand Name: SABER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• MDR Report Key: 17154981
• Report Number: 3007635982-2023-00216
• Device Sequence Number: 14896318
• Product Code: LIT
• UDI-Device Identifier: 20705032069554
• UDI-Public: (01)20705032069554(17)250630(10)82246696
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/19/2023

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?: No
• Device Model Number: 48005020X
• Device Catalogue Number: 48005020X
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown