MAUDE Adverse Event Report: CORDIS US CORP. SABER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	48005006X
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product history record (phr) review of lot 82205303 revealed no anomalies or non-conformances during the manufacturing and inspection processes that could be associated with the event reported.The device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the balloon of a 5mm x 6cm saber percutaneous transluminal angioplasty (pta) dilatation catheter would not inflate within the artery and appeared to have a hole in it.Pressure was not maintained and contrast leaked out from a hole in the balloon.The gauge of the indeflator indicated a loss of pressure when the anomaly was noted.The procedure was completed with a new unknown balloon.There was no reported patient injury.The intended procedure was reported to be an angiogram with runoff.The target lesion was the superficial femoral artery (sfa).Vessel calcification and tortuosity was mild.The device was not used for a chronic total occlusion (cto).The device was stored, handled, and prepped according to the instructions for use (ifu).There were no visible signs of device/package damage prior to use.There was no difficulty removing the product from the hoop or removing the protective balloon cover nor difficulty removing the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.The device maintained negative pressure during preparation.The contrast to saline ratio was 50:50.The same indeflator was successfully used with other devices.There were no anomalies noted while inflating the device with positive pressure and no device anomaly which prevented it from inflating.
Additional Manufacturer Narrative
As reported, the balloon of a 5mm x 6cm saber percutaneous transluminal angioplasty (pta) dilatation catheter would not inflate within the artery and appeared to have a hole in it.Pressure was not maintained, and contrast leaked out from a hole in the balloon.The gauge of the indeflator indicated a loss of pressure when the anomaly was noted.The procedure was completed with a new unknown balloon.There was no reported patient injury.The intended procedure was reported to be an angiogram with runoff.The target lesion was the superficial femoral artery (sfa) with vessel calcification and tortuosity was mild.The device was not used for a chronic total occlusion (cto).The device was stored, handled, and prepped according to the instructions for use (ifu).There were no visible signs of device/package damage prior to use.There was no difficulty removing the product from the hoop, the protective balloon cover, the stylet, or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.The device maintained negative pressure during preparation.The contrast to saline ratio was 50:50.The same indeflator was successfully used with other devices.There were no anomalies noted while inflating the device with positive pressure and no device anomaly which prevented it from inflating.The device was returned for analysis.A non-sterile saber 5mm x 6cm 150 was received coiled inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.The unit was thoroughly inspected observing that no damages or anomalies were observed during the unaided eye visual inspection.The balloon was received deflated.Per functional testing, one inflator/deflator device was attached to the inflation port, positive pressure was applied with the purpose of reaching the rated burst pressure.During this test it was observed that a leak was present in the balloon body as it was reported.Sem analysis was executed to evaluate the surface of the balloon received.During the sem analysis scratch marks were observed near the punctured borders of the balloon received.The scratch marks observed could be related to the interaction of the balloon material with a sharp object or mechanical damage.A product history record (phr) review of lot 82205303 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¿ was confirmed during device analysis.The exact cause could not be determined.Functional analysis revealed a puncture to the surface of the balloon material and a leakage of water was noted when the balloon was inflated.It is likely vessel characteristics of calcification and mild vessel tortuosity and/or procedural factors contributed to the reported event as evidenced by device analysis.Calcification is known to damage balloon material; it is likely damage occurred during crossing or in the attempt to inflate the balloon at the lesion.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
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; coyol free zone, building b25; el coyol alajuela bld 25, costa rica ; 7863138372
• MDR Report Key: 17743603
• Report Number: 3007635982-2023-00296
• Device Sequence Number: 5654478
• Product Code: LIT
• UDI-Device Identifier: 20705032068137
• UDI-Public: 20705032068137
• Combination Product (Y/N): N
• 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): Unknown
• 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): 11/20/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 48005006X
• Device Lot Number: 82205303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2020
• 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: BOSTON SCIENTIFIC INFLATION DEVICE; CONTRAST MEDIA: OMNIPAQUE
• Patient Sex: Unknown