MAUDE Adverse Event Report: CORDIS CORPORATION SABER 2MM2CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48002002X

Device Problems Partial Blockage (1065); Difficult to Advance (2920); Material Integrity Problem (2978)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2022

Event Type  malfunction  

Manufacturer Narrative

The product history review is expected but has not been completed. 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.

Event Description

As reported, while performing preconditioning testing for saber over the wire (otw), an obstruction of foreign material was found inside of the guidewire lumen of a 2mm x 2cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter. As mentioned, this was during preconditioning testing of the device and there was no patient involvement or clinical use of the device. The sample was successfully flushed; however, during the guidewire insertion portion of the sample prep, the guidewire failed to pass through the lumen and out of the hub. Upon review of the device, an obstruction was seen in the lumen near the hub. An inflation device with filtered water was then used to flush the injection lumen. I was reported that 30 atmospheres (atm) of pressure was required to dislodge the obstructing material from the balloon catheter. The device along with the obstructing material was sent to the analytical lab for further analysis.

• Brand Name: SABER 2MM2CM 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: 13904804
• MDR Text Key: 290463093
• Report Number: 9616099-2022-05487
• 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: Other,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 48002002X
• Device Catalogue Number: 48002002X
• Device Lot Number: 82230564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 03/25/2022 Patient Sequence Number: 1

Treatment

UNK GUIDEWIRE