MAUDE Adverse Event Report: CORDIS CORPORATION SABER 2.5MM25CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48002525X

Device Problem Material Puncture/Hole (1504)

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

Event Date 11/09/2021

Event Type  malfunction  

Event Description

During use, the saber 2. 5mm x 25cm balloon catheter and balloon were punctured by the wire when loading it over the wire. There was no patient injury. The device was prepped per the instruction for use (ifu) and there were no difficulty noted in the balloon during prep. There were no difficulties removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components. There were no kinks or other damages noted prior to inserting the product the product into the patient. Femoral retrograde access was made. The balloon was discarded and will not be returned for analysis. No other information was provided.

Manufacturer Narrative

This device is not available for testing and evaluation. Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: SABER 2.5MM25CM 150
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12960439
• MDR Text Key: 286062572
• Report Number: 9616099-2021-05139
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 48002525X
• Device Catalogue Number: 48002525X
• Device Lot Number: 82226769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/08/2021 Patient Sequence Number: 1

Treatment

UNK WIRE.