MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX5MM15CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 51005015L

Device Problem Deflation Problem (1149)

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

Event Date 03/15/2022

Event Type  Injury  

Event Description

As reported, there was difficulty advancing a 5mm x 15cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter towards a shunt lesion. The device was able to cross the lesion; however, after an inflation to 8 atmospheres (atm), the balloon was unable to be deflated. As a result, the physician pulled the balloon back to a point where an intentional separation of the device could be made in order to deflate the balloon and remove the device. It was reported that none of the device pieces had been left inside of the patient and the procedure was completed after its their removal. This was during a pta procedure to treat a shunt lesion in the axillary vein. The lesion had mild calcification, mild tortuosity, a 99% stenosis, and was not a chronic total occlusion (cto). The device was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation. There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components and the device was not kinked or damaged in any way prior to being inserted into the patient. There was no resistance or friction as the balloon catheter was being inserted into the patient, the device was never in an acute bend, and there were no kinks observed on the device. Information regarding the contrast used, contrast to saline mixture, type of inflation device used, guidewire used was requested but was not provided. Additionally, procedural films were requested but are unavailable. The device will be returned for evaluation.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82193117 presented no issues during the manufacturing process that can be related to the reported event. This device is available for analysis, but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt. Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: SABER RX5MM15CM155
• 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: 14100917
• MDR Text Key: 289173023
• Report Number: 9616099-2022-05538
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 51005015L
• Device Lot Number: 82193117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2020
• 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: 04/13/2022 Patient Sequence Number: 1