MAUDE Adverse Event Report: CORDIS CORPORATION SABER 2.5MM30CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48002530X

Device Problems Partial Blockage (1065); Material Frayed (1262); Material Split, Cut or Torn (4008)

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

Event Date 09/28/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported, a non-cordis. 018 wire became stuck inside the lumen of a saber 2. 5mm 30cm 150cm balloon catheter. Also reported, it appeared the coating inside the catheter was peeled off. The wire and balloon catheter were removed intact from the patient. There was no reported patient injury. The device was stored per the instructions for use (ifu). There was no difficulty removing the product from the packaging. There were no anomalies noted to the device after removed from the packaging. The device was prepped per the ifu without any difficulty noted. The inner stylet was removed from the balloon catheter. A 6f non-cordis sheath was inserted into the femoral artery in attempt to treat the anterior tibial (at). The target site had a 100% stenosis (chronic total occlusion) with mild calcification. After the balloon crossed the lesion and after dilation, the wire got stuck post dilation. There was no resistance/friction noted while advancing the catheter through the sheath. There was no unusual force used during the procedure. Another unknown balloon catheter and wire was used to complete the case. The device will be returned for evaluation.

• Brand Name: SABER 2.5MM30CM 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: 12689734
• MDR Text Key: 278150616
• Report Number: 9616099-2021-05001
• 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: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 48002530X
• Device Catalogue Number: 48002530X
• Device Lot Number: 82226780
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2021
• 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: 10/25/2021 Patient Sequence Number: 1

Treatment

SABER BALLOON; UNKNOWN WIRE