MAUDE Adverse Event Report: CORDIS CORPORATION SABER 5MM25CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48005025X

Device Problem Deflation Problem (1149)

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

Event Date 03/30/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported, a 5mm x 25cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter was unable to cross the distal end of a lesion and, after a normal inflation of the balloon to nominal pressure, the balloon was extremely difficult to deflate. The balloon was eventually deflated on its own and was removed easily from the patient in one piece. Another 5mm x 25cm 150cm saber pta balloon catheter from a different lot was used in place of the initial saber pta balloon catheter; however, during an inflation to nominal pressure, the balloon of the second 5mm x 25cm 150cm saber pta balloon catheter ruptured. The ruptured 5mm x 25cm 150cm saber pta balloon catheter was then removed and a 5mm x 20cm saber pta balloon catheter was used without issue. There was no reported injury to the patient. This was during a procedure to treat a calcified lesion in which a non-cordis. 014 guidewire was used and there was no observed damage to this guidewire. Both of the 5mm x 25cm 150cm saber pta balloon catheters were stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation. There was no difficulty removing the devices from their hoop, removing their protective balloon covers, their stylets, any of their sterile packaging components, and the devices were not kinked or damaged in any way prior to being inserted into the patient. A mixture of 1/3rd contrast and 2/3rd saline was used to prep the balloons. A non-cordis 60cc syringe was used for inflation of the saber pta balloon catheters and was successfully used with other devices during this procedure. The saber pta balloon catheters were never in an acute bend and neither device had kinked during its use. The second 5mm x 25cm 150cm saber pta balloon catheter did not experience any issues tracking towards the lesion and was able to cross the lesion with ease. After the second saber pta had ruptured, the device was able to be removed easily and remained in one piece. Information regarding the patient and possible procedural film was requested but was not provided, and both the devices will be returned for evaluation.

• Brand Name: SABER 5MM25CM 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: 14192178
• MDR Text Key: 289958778
• Report Number: 9616099-2022-05589
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 48005025X
• Device Catalogue Number: 48005025X
• Device Lot Number: 82206150
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2020
• 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: 04/25/2022 Patient Sequence Number: 1

Treatment

5MM X 20CM SABER PTA BALLOON CATHETER/48005020X; OMNIPAQUE 300 CONTRAST; V-14 .014 GUIDEWIRE