MAUDE Adverse Event Report: CORDIS CORPORATION SABER 3.5MM15CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48003515X
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2022
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, the saber 3.5mm 15cm 150 had something stuck inside the balloon; therefore, the non-cordis wire could not pass through the device.The case was completed with a new cordis balloon catheter.There was no reported injury to the patient.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover, stylet, or any of the sterile packaging components.The device was never inserted into the patient.The device was attempted to be prepped per the ifu.The obstruction was noticed while pre-loading outside the patient onto the non-cordis guidewire.The catheter was never in an acute bend and the catheter was never kinked.The device will not be returned for evaluation as multiple attempts were made without success.
Event or Problem Description
As reported, the saber 3.5mm 15cm 150 had something stuck inside the balloon; therefore, the non-cordis wire could not pass through the device.The case was completed with a new cordis balloon catheter.There was no reported injury to the patient.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover, stylet, or any of the sterile packaging components.The device was never inserted into the patient.The device was attempted to be prepped per the ifu.The obstruction was noticed while pre-loading outside the patient onto the non-cordis guidewire.The catheter was never in an acute bend and the catheter was never kinked.The device will not be returned for evaluation as multiple attempts were made without success.
Additional Manufacturer Narrative
As reported, the saber 3.5mm 15cm 150 had something stuck inside the balloon; therefore, the non-cordis wire could not pass through the device.The case was completed with a new cordis balloon catheter.There was no reported injury to the patient.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover, stylet, or any of the sterile packaging components.The device was never inserted into the patient.The device was attempted to be prepped per the ifu.The obstruction was noticed while pre-loading outside the patient onto the non-cordis guidewire.The catheter was never in an acute bend and the catheter was never kinked.The device was not returned for evaluation as multiple attempts were made without success.A product history record (phr) review of lot 82183812 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿guidewire lumen- obstructed - during prep¿ was not confirmed as the device was not returned for analysis.The exact cause could not be determined.It is likely procedural factors and handling of the device may have contributed to the event reported by the customer.Use of the device with the concomitant hydrophilic wire may also be a contributing factor.However, without the return of the device for analysis or concomitant wire used with the device, it is difficult to draw a clinical conclusion between the device and the event reported.According to the warnings in 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.Flush all devices entering the vascular system with sterile heparinized saline or similar isotonic solution.Prior to use, ensure all devices have been flushed and air is removed from the system according to standard medical practice.Failure to do so could result in air entering the vascular system.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: SABER 3.5MM15CM 150
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 32574
• 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: 14465017
• Report Number: 9616099-2022-05650
• Device Sequence Number: 14581780
• Product Code: LIT
• UDI-Device Identifier: 20705032069387
• UDI-Public: (01)20705032069387(17)221231(10)82183812
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/26/2022

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: 12/31/2022
• Device Model Number: 48003515X
• Device Catalogue Number: 48003515X
• Device Lot Number: 82183812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 05/21/2022
• Supplement Report FDA Received Date: 05/26/2022
• Date Device Manufactured: 01/02/2020
• 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: CORDIS BALLOON; UNK WIRE
• Patient Sex: Unknown