MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO SABER 4MM4CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number N/A

Device Problem Partial Blockage (1065)

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

Event Date 09/02/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned but the engineering report is pending. A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan. Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

During the device preparation procedure, the 4mm x 4cm 150 saber percutaneous transluminal angioplasty (pta) balloon catheter could not be flushed because the unknown guidewire lumen port on the balloon was clogged/blocked caused by a blockage of possibly injectable material. So, it could not be used on patient and another saber was used to complete the procedure without any problem. There was no reported patient injury. A percutaneous transluminal angioplasty (pta) of the superficial femoral artery (sfa) was being performed. There was no damage to the device noticed prior to opening the package. There was no difficulty removing the device from the sterile packaging. The device was stored and prepped per the instructions for use. The event occurred during the initial use of the device. Patient demographics and medical history were requested but were not available. The device will be returned for analysis.

• Brand Name: SABER 4MM4CM 150
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• Manufacturer (Section G): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; MX 33014 ; 7863138372
• MDR Report Key: 12568371
• MDR Text Key: 274522150
• Report Number: 9616099-2021-04905
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 48004004X
• Device Lot Number: 82216762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2021
• 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: 10/04/2021 Patient Sequence Number: 1

Treatment

UNKNOWN GUIDEWIRE