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

Catalog Number	48006015X
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: as reported, the guidewire delivery lumen at the tip end of the balloon on a 6mm x 15cm saber percutaneous transluminal angioplasty (pta) dilation catheter is a fraction shorter.There were no reports of patient injury.Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.The device was returned for evaluation.A non-sterile ¿saber 6mm15cm 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 the distal tip presents a separated condition.The separated piece was not returned for analysis.The balloon was received uninflated.Not other outstanding details were observed.The tip seal melt zone was verified, and dimensional analysis results were found within specification.Dimensional analysis was performed to verify the correct id of the distal tip, and the results were found within specification.The distal tip area was inspected using a vision system to obtain a magnified image.Side view of the separation was inspected observing a clean cut.The distal tip and the inner lumen appear to have proper fusion.Front view shows a smooth surface with microscopic elongations in the edge and grind marks.These characteristics are presents when the plastic material is cut with a sharp tool.The reported ¿distal tip separated¿ was observed as the device was returned with the distal tip separated, and the separated portion was not returned for analysis.Vision system magnification showed that the separation on the distal tip of the device presented evidence of microscopic elongations and grind marks on the edge of the distal tip suggestive of a clean cut.Several factors are being considered, and further investigation is required to find a definitive root cause.Therefore, based on the information available for review, it is difficult to draw a clinical conclusion between the device and the events reported as further investigation is warranted.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.If resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.Proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.Always verify integrity of the catheter after removal.¿ the information available and product analysis suggest a possible manufacturing related cause for the reported event experienced by the customer.Further investigation to determine root cause required; therefore, an investigation has been initiated.
Event or Problem Description
As reported, the guidewire delivery lumen at the tip end of the balloon on a 6mm x 15cm saber percutaneous transluminal angioplasty (pta) dilation catheter is a fraction shorter.There were no reports of patient injury.Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.The device was returned for evaluation.The unit was thoroughly inspected observing a separation condition at the distal tip.

• Brand Name: SABER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; coyol free zone, building b25, , , costa rica; el coyol alajuela bld 25 CR201-02 ; CS CR20102
• MDR Report Key: 21755156
• Report Number: 3007635982-2025-00071
• Device Sequence Number: 9749033
• Product Code: LIT
• UDI-Device Identifier: 20705032069622
• UDI-Public: (01)20705032069622(17)270531(10)82312413
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2025

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 Catalogue Number: 48006015X
• Device Lot Number: 82312413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2025
• 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: 03/24/2025
• Initial Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2024
• 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: 18 GUIDEWIRE-CONNECT FLEX; 18 GUIDEWIRE-V18; 35 BALL-MUSTANG; 35 GUIDEWIRE-COOK; SHEATH-CATHETER SHEATH DEVICE; SHEATH-CROSSOVER LONG SHEATH; STENT-INNOVA
• Patient Sex: Unknown