MAUDE Adverse Event Report: CORDIS CORPORATION SABER 6MM4CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48006004X
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, prior to entering the patient, the distal tip of a 6mm x 4cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter was found to be fractured.There was no reported injury to the patient.The tip of the balloon did not embolize and there was no need for retrieval of any part of the device as the device was never used inside of the patient.The device will be returned for evaluation.
Event or Problem Description
As reported, prior to entering the patient, the distal tip of a 6mm x 4cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter was found to be fractured.There was no reported injury to the patient.The tip of the balloon did not embolize and there was no need for retrieval of any part of the device as the device was never used inside of the patient.Additional information was requested but was not provided, and the device was not returned as expected.
Additional Manufacturer Narrative
Complaint conclusion: as reported, prior to entering the patient, the distal tip of a 6mm x 4cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter was found to be fractured.There was no reported injury to the patient.The tip of the balloon did not embolize and there was no need for retrieval of any part of the device as the device was never used inside of the patient.Additional information was requested but was not provided.The device was not returned for evaluation as expected.A product history record (phr) review of lot 82234660 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿distal tip cracked - during prep¿ could not be confirmed as the device was not returned for analysis.The exact cause cannot be determined.Based on the information available for review, it is likely handling of the device and/or procedural factors contributed to the reported event.Damages may have ensued during removal of the balloon protective sheath during device preparation.However, without the return of the device for analysis, and with the limited amount of information provided, 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.

• Brand Name: SABER 6MM4CM 150
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14268766
• Report Number: 9616099-2022-05605
• Device Sequence Number: 11971998
• Product Code: LIT
• UDI-Device Identifier: 20705032068175
• UDI-Public: (01)20705032068175(17)240930(10)82234660
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2022

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: 09/30/2024
• Device Model Number: 48006004X
• Device Catalogue Number: 48006004X
• Device Lot Number: 82234660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/07/2022
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 05/03/2022
• Supplement Report FDA Received Date: 05/11/2022
• Date Device Manufactured: 10/27/2021
• 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
• Patient Sex: Unknown