MAUDE Adverse Event Report: CORDIS CORPORATION SABER035 9MM4CM 80 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48009004N

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the marker bands of a 0. 035¿ 9mm x 4cm x 80cm saber percutaneous transluminal angioplasty (pta) balloon catheter (bc) lacks visibility. The procedure was completed normally, but with a poor visibility of the marker bands, having a negative impact on the accuracy of the balloon placement. There was no reported patient injury. The saber was not exposed to long periods of sunlight in the receiving area. The humidity was not controlled in this room. The saber was stored there for around 2 days before it was distributed to the cath lab. The saber was not exposed to long periods of sunlight, high temperatures or increased humidity at any time prior to use in the cath lab. The balloon cover/sheath and shipping stylet were removed separately. There was no damage noted to the product¿s packaging prior to opening. There were no anomalies noted when the saber was removed from its packaging. There were no kinks noted on the device in the affected region. The intended procedure was an iliac procedure. The lesion was moderately calcified. There was no vessel tortuosity. The device was not used for a chronic total occlusion (total occlusion >3 months). The device was stored and handled per the instruction for use (ifu). There was no difficulty removing the product from the hoop. There was difficulty removing the protective balloon cover. There was no difficulty removing the stylet or any of the sterile packaging components. There were no kinks nor other damages noted prior to inserting the product into the patient. The device was prepped normally (i. E. Maintain negative pressure). An indeflator inflation device was used. The same indeflator was used successfully with other devices. There was resistance/friction while inserting the balloon through the rotating hemostatic valve. There was no resistance/friction while inserting the balloon through the guide catheter. There was no difficulty advancing the balloon catheter through the vessel. There was no difficulty crossing the lesion. The catheter was never in an acute bend. The catheter was not torqued against resistance. The catheter was not re-shaped by the user. The product was removed intact (in one piece) from the patient. All the marker bands were accounted for after removal of the device.

• Brand Name: SABER035 9MM4CM 80
• Type of Device: 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: 11273582
• MDR Text Key: 230262446
• Report Number: 9616099-2021-04232
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 48009004N
• Device Catalogue Number: 48009004N
• Device Lot Number: 82195452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial