MAUDE Adverse Event Report: CORDIS US CORP. SABER035; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	48008010N
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
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 markers of a saber 0.35 8x100 mm percutaneous transluminal angioplasty (pta) dilatation catheter were not clear under fluoroscopy; they had trouble with the visibility on screening.The product was removed intact (in one piece) form the patient.All the marker bands (proximal and distal) were present on the device.There was no reported patient injury.Additional event details were requested; however, not provided.The device is expected to be returned for evaluation.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
A product history record (phr) review of lot 82246322 revealed no anomalies or non-conformances during the manufacturing and inspection processes that could be associated with the event reported.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.
Additional Manufacturer Narrative
The balloon markers of a saber 0.35 8x100 mm percutaneous transluminal angioplasty (pta) dilatation catheter were not clear under fluoroscopy; they had trouble with the visibility on screening.The product was removed intact (in one piece) from the patient.All the marker bands (proximal and distal) were present on the device.There was no reported patient injury.Additional event details were requested; however, not provided.The product was returned for analysis.A non-sterile saber.035 8x100mm 80cm pta catheter was received coiled inside of a clear plastic bag.Per visual analysis the device does not present with any damages or anomalies.The balloon was received without being inflated.Per functional analysis the marker bands were visible during the analysis and were easily identified.Per microscopic analysis, the marker bands were identified in the expected positions.A product history record (phr) review of lot 82246322 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿marker band - inadequate radiopacity¿ was not confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.The marker bands were located inside the balloon and during the rx test opacity were expressed per the marker bands as expected.According to the safety information in the instructions for use, ¿the cordis saber tm percutaneous transluminal angioplasty (pta) dilatation catheter is a catheter with a distal inflatable balloon.Radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement.For balloon lengths greater than or equal to 100mm, the distal section will have one (1) marker band and proximal section will consist of two (2) adjacent marker bands.For balloon lengths less than 100mm, the distal and proximal section will have each one (1) marker band.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.¿ neither the phr review nor the product analysis 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: SABER035
• 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: 17467142
• Report Number: 3007635982-2023-00251
• Device Sequence Number: 12987132
• Product Code: LIT
• UDI-Device Identifier: 20705032080375
• UDI-Public: 20705032080375
• 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
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/23/2023

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 Catalogue Number: 48008010N
• Device Lot Number: 82246322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/19/2023
• Supplement Date Received by Manufacturer: 08/16/2023; 09/13/2023; 10/16/2023
• Initial Report FDA Received Date: 08/05/2023
• Supplement Report FDA Received Date: 08/30/2023; 09/14/2023; 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2022
• 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: (B)(6) 2023.
• Patient Sex: Unknown