MAUDE Adverse Event Report: CORDIS CORPORTION SABER 5MM4CM 90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number N/A

Device Problems Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)

Patient Problems Myocardial Infarction (1969); Pneumonia (2011)

Event Date 09/09/2019

Event Type  Injury  

Manufacturer Narrative

The device was returned but the engineering report is pending. A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan. Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

When performing a recanalisation of the common iliac artery with a 5x40 mm saber balloon to create a larger lumen for a bigger balloon, the balloon burst during dilatation, and was stuck. When they tried to pull the balloon, it split up and a piece of it was stuck in the artery. It was dragged down to common femoral artery with a guidewire that also was also stuck in a piece of the balloon. The balloon piece was removed with a surgery via the groin with general anesthesia. The patient had a postoperative heart attack and died one week later. The patient remained hospitalized following the surgery and heart attack. An autopsy was not performed. The death certificate listed the official cause of death as heart attack and pneumonia. The device will be returned for analysis. The lesion was calcified and a chronic total occlusion (cto). There were no kinks or other damages noted prior to inserting the product the product into the patient. The device prepped normally. The brand of contrast was omnipak 300 at a 50:50 contrast to saline ratio with an everest inflation device by medtronic. The same indeflator was used successfully with other devices. There was no resistance/friction while inserting the balloon through the rotating hemostatic valve. There was no resistance/friction while inserting the balloon through the guide catheter. There difficulty advancing the balloon catheter through the vessel and crossing the lesion. The catheter was never in an acute bend. The balloon inflated normally and the maximum inflation pressure was 5-6 atmospheres. The balloon was not caught in the lesion or in a deployed stent. There was resistance met while withdrawing the device from the vessel, into the guide catheter, into the introducer guide and through the hemostasis valve. The patient had the heart attack a few hours after the procedure which was treated medically.

• Brand Name: SABER 5MM4CM 90
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORTION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 9179219
• MDR Text Key: 162049611
• Report Number: 9616099-2019-03268
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 48005004S
• Device Lot Number: 17683882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2017
• 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: 10/11/2019 Patient Sequence Number: 1