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

Model Number	R51008004L
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product history record review is anticipated; however, it has not yet been finalized.The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the balloon of a saberx radianz 8mm x 4cm 190 percutaneous transluminal angioplasty (pta) dilatation catheter ruptured within its nominal pressure when it was used for post dilation.Deflation was not good; therefore, the complaint device was moved before being deflated completely, which damaged the complaint device.There was no reported patient injury.The lesion was the iliac artery.An approach was made from the radial region.The saberx pta was used as pre-dilation and smart stent(s) were implanted.The device is expected to be returned for evaluation.
Additional Manufacturer Narrative
The balloon of a saberx radianz 8mm x 4cm 190 percutaneous transluminal angioplasty (pta) dilatation catheter ruptured within its nominal pressure when it was used for post dilation.Deflation was not good; therefore, the complaint device was moved before being deflated completely, which damaged the complaint device.There was no reported patient injury.The lesion was the iliac artery.An approach was made from the radial region.The saberx pta was used as pre-dilation and smart stent(s) were implanted.The product was not returned for analysis.A product history record (phr) review of lot 82246656 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Procedural or handling factors or vessel characteristics (although unknown) may have contributed to the reported event as the presence of calcification is known to cause damage to balloons.According to the safety information in the instructions for use, ¿prior to angioplasty, the catheter should be examined to verify functionality and integrity, and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Do not use if product damage is suspected or evident.To reduce the potential for vessel damage or the risk of dislodgement of particles it is very important that the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the lesion.The balloon dimensions are printed on the product label.The compliance table incorporated with the product shows how balloon diameter increases as pressure increases.Do not exceed the rated burst pressure recommended on the label.The rated burst pressure is based on the results of in vitro testing.At least 99.9% of the balloons (with a 95% confidence) will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over-pressurization.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.Balloon rupture can cause vessel damage and the need for additional intervention.¿ neither the phr review nor the limited information provided suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: SABERX RADIANZ
• 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
• MDR Report Key: 16886570
• Report Number: 3007635982-2023-00172
• Device Sequence Number: 20411177
• Product Code: LIT
• UDI-Device Identifier: 20705032081471
• UDI-Public: (01)20705032081471(17)250430(10)82246656
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2023

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: 04/30/2025
• Device Model Number: R51008004L
• Device Catalogue Number: R51008004L
• Device Lot Number: 82246656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 05/26/2023
• Date Device Manufactured: 05/02/2022
• 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: SMART STENT.
• Patient Sex: Unknown