MAUDE Adverse Event Report: CORDIS CORPORATION SABER 3MM6CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48003006X
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a 3mm x 6cm 150 saber percutaneous transluminal angioplasty (pta) balloon catheter was attempted to inflate; however, the operator noticed leakage from the balloon, and it would not inflate to its nominal pressure.The balloon was then removed, and additional balloon (unknown) was opened to finish the case.There was no reported patient injury.The saber was opened in a sterile field as per instructions for use (ifu).The saber was prepped and inserted over the wire (unknown) to the target vessel.The device will not be returned for evaluation as it was already discarded in the facility.Additional information was requested; however, the information was not obtained.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82191546 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.
Additional Manufacturer Narrative
As reported, a 3mm x 6cm 150 saber percutaneous transluminal angioplasty (pta) balloon catheter was attempted to inflate; however, the operator noticed leakage from the balloon, and it would not inflate to its nominal pressure.The balloon was then removed, and additional balloon (unknown) was opened to finish the case.There was no reported patient injury.The saber was opened in a sterile field as per instructions for use (ifu).The saber was prepped and inserted over the wire (unknown) to the target vessel.Additional information was requested; however, the information was not obtained.The device was not returned for analysis as it was discarded in the facility.A product history record (phr) review of lot 82191546 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon leakage - during positive pressure¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.It is likely vessel characteristics, although unknown, or procedural factors may have contributed to the reported event.However, without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and the event reported.According to the instructions for use, which are not intended to mitigate risk, ¿preparation 1.Attach a 3-way stopcock to the inflation port, which is marked ¿balloon¿.2.Attach a partially filled syringe with heparinized saline to the stopcock, open the stopcock to the balloon and induce negative pressure.3.Hold the syringe and proximal end of the catheter above the distal end of the catheter, and hold the balloon vertically with the balloon tip pointing down.4.While maintaining negative pressure close the stopcock to the inflation port.Remove the syringe and purge the air.5.To ensure air contained in the balloon and inflation lumen is removed, apply negative pressure twice as instructed and repeat steps 2-4.6.Without twisting, slide the forming tube off the balloon.7.Prepare an angioplasty inflation system with a 50% solution of contrast medium in sterile saline or similar solution.8.Purge the air from the inflation device.9.Connect the inflation device to the 3-way stopcock that is connected to the catheter inflation port, open the stopcock to the catheter and slowly fill the inflation lumen and the balloon will slowly fill with diluted contrast medium.¿ neither the phr review nor the analysis results suggest that the reported event is related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: SABER 3MM6CM 150
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12787625
• Report Number: 9616099-2021-05048
• Device Sequence Number: 7815356
• Product Code: LIT
• UDI-Device Identifier: 20705032069325
• UDI-Public: (01)20705032069325(17)230430(10)82191546
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K971010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2021

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 Expiration Date: 04/30/2023
• Device Model Number: 48003006X
• Device Catalogue Number: 48003006X
• Device Lot Number: 82191546
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2021
• Supplement Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 11/15/2021
• Date Device Manufactured: 05/08/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK WIRE
• Patient Sex: Unknown