MAUDE Adverse Event Report: CORDIS CORPORATION SABER 3MM6CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48003006X

Device Problem Leak/Splash (1354)

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

Event Date 10/14/2021

Event Type  malfunction  

Event Description

As reported, a 3mm x 6cm 150 saber percutaneous transluminal angioplasty (pta) balloon catheter was attempted to inflate; however, the operator noticed leakage from the balloon, and it would not inflate to its nominal pressure. The balloon was then removed, and additional balloon (unknown) was opened to finish the case. There was no reported patient injury. The saber was opened in a sterile field as per instructions for use (ifu). The saber was prepped and inserted over the wire (unknown) to the target vessel. The device will not be returned for evaluation as it was already discarded in the facility. Additional information was requested; however, the information was not obtained.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82191546 presented no issues during the manufacturing process that can be related to the reported event. Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: SABER 3MM6CM 150
• 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: 12787625
• MDR Text Key: 284380717
• Report Number: 9616099-2021-05048
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 48003006X
• Device Catalogue Number: 48003006X
• Device Lot Number: 82191546
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 05/08/2020
• 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: 11/10/2021 Patient Sequence Number: 1

Treatment

UNK WIRE