MAUDE Adverse Event Report: CORDIS CORPORATION SABER 5MM8CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48005008X
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	08/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: as reported, the tip of a 5mm x 8cm x 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter came off when it was loaded over a.018¿ unknown wire.There was no reported patient injury.The product was stored as per labeling.The device was opened in a sterile field.The device was not used in a patient.The intended procedure was a superficial femoral artery (sfa) angioplasty.The device was not resterilized.There were no anomalies noted when removed from the package.There were no anomalies noted during prep.The device was not inserted through a stopcock instead of a hemostatic valve.The device did not kink in the area of separation.A new balloon was opened, and the user continued with the procedure successfully.The device was not returned for evaluation.A product history record (phr) review of lot 82205433 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaint reported by the customer as ¿distal tip separated¿ was not confirmed as the device was not returned for analysis.The exact cause cannot be determined.Handling of the device and procedural factors likely 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 safety information in the instructions for use ¿prepare an angioplasty inflation system with a 50% solution of contrast medium in sterile saline or similar solution.Without twisting, slide the forming tube off the balloon.Prepare an angioplasty inflation system with a 50% solution of contrast medium in sterile saline or similar solution.Place the prepared catheter over a prepositioned guidewire and advance the tip to the introduction site.Note: balloon inflation should be performed with the guidewire extended beyond the catheter tip.It is strongly recommended that the guidewire, the balloon catheter, or both, remain across the lesion until the procedure is complete and the dilatation system is to be removed from the vessel.Note: to preserve the folded balloon shape during insertion and catheter manipulation, maintain a vacuum on the inflation lumen.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.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.¿ neither the phr review nor the product analysis suggests that the found damages could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.
Event or Problem Description
As reported, the tip of a 5mm x 8cm x 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter came off when it was loaded over a.018¿ unknown wire.There was no reported patient injury.The product was stored as per labeling.The device was opened in a sterile field.The device was not used in a patient.The intended procedure was a superficial femoral artery (sfa) angioplasty.The device was not resterilized.There were no anomalies noted when removed from the package.There were no anomalies noted during prep.The device was not inserted through a stopcock instead of a hemostatic valve.The device did not kink in the area of separation.A new balloon was opened, and the user continued with the procedure successfully.The device will be returned for evaluation.

• Brand Name: SABER 5MM8CM 150
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12382569
• Report Number: 9616099-2021-04817
• Device Sequence Number: 4699176
• Product Code: LIT
• UDI-Device Identifier: 20705032069585
• UDI-Public: (01)20705032069585(17)230930(10)82205433
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2021

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: 09/30/2023
• Device Model Number: 48005008X
• Device Catalogue Number: 48005008X
• Device Lot Number: 82205433
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN 018 WIRE