MAUDE Adverse Event Report: CORDIS CORPORATION SABER 5MM30CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48005030X

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot (17691860) 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.

Event Description

As reported, cracks in the ¿interface¿ of a 5mm x 30cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter were found in preparation for the ¿second balloon filling¿. There was no reported patient injury. The user was trained with the device. The device was opened in the sterile field. The type of damage noted on the device that it was cracked. The device damaged was noted during use. The device was stored and handled per the instructions for use (ifu). There was no damage noted to the package. There were no visible signs of device/package damage prior to use. There were no anomalies noted when the device was taken out of the package. There was no excessive force applied to the device during withdrawal from package. The integrity of the sterile pouch was not compromised. The device was not used in patient. The device will be returned for evaluation.

• Brand Name: SABER 5MM30CM 150
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 10296116
• MDR Text Key: 199684624
• Report Number: 9616099-2020-03792
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/30/2020
• Device Model Number: 48005030X
• Device Catalogue Number: 48005030X
• Device Lot Number: 17691860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial