• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER 2MM15CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CORDIS CORPORATION SABER 2MM15CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 48002015X
Device Problems Partial Blockage (1065); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/15/2022
Event Type  malfunction  
Manufacturer Narrative
As reported, a non-cordis. 018 guidewire was unable to pass through a 2mm x 15cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter while being pre-loaded outside of the patient. Additionally, it was reported there was difficulty experienced when attempting to flush the saber pta balloon catheter during preparation. As a result, a 2mm x 20cm 150cm saber pta balloon catheter was successfully used to complete the procedure and there was no reported injury to the patient. The 2mm x 15cm 150cm saber pta balloon catheter was prepped per the instructions for use (ifu) and there were no observed kinks to the device. The non-cordis guidewire that was used was not damaged in any way and was used successfully with other devices during this procedure. The target lesion was calcified and had a stenosis of 80%; however, there was no evidence of an acute angle or bifurcation present at the target site. Information regarding the target site, vessel tortuosity, and the possibility of an injectable obstruction was requested but not provided. The device was returned for analysis. A non-sterile saber 2mm x 15cm 150 percutaneous transluminal angioplasty (pta) balloon catheter was received for analysis coiled inside a plastic bag. Per visual analysis, neither anomalies nor damages could be observed. Per functional analysis, gw lumen flushing was intended to be performed; however, flushing could not be achieved. Next, an appropriate. 018¿ lab sample guidewire was inserted via tip and vice versa, then via the hub with unsuccessful results. The guidewire could not entirely pass through the guidewire lumen of the unit. The guidewire was advanced and stopped at 52cm from the distal tip and no longer advanced as an obstruction was felt at this point. Per microscopic analysis, the unit was inspected under the vision system. It was confirmed that the. 018¿ gw was stopped at the obstructed area at 52cm from the distal tip. The guidewire lumen was cut/dissected at the obstructed area and a piece of detached inner body polyethylene tucked inside the guidewire lumen was observed, the polyethylene was removed from the gw lumen. The polyethylene material was observed kind of accordioned (zigzag) inside the guidewire lumen and once removed, the material unraveled. The inner body of the unit was cut lengthwise near the obstructed area to obtain images of the possible damages at this affected area. Due to the observed damages in the interior of the inner body, sem analysis was performed. Results showed that the damaged area of the inner body of the saber 2mm x 15cm 150 unit presented evidence of polyethylene damages that could be caused by the cut performed on the inner body. However, evidence of scratches and deformations were noted on the lumen of the inner body. These damages could be caused by a rigid object that passed along the lumen of the unit. No other anomalies were observed during sem analysis. A product history record (phr) review of lot 82221979 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿pta/ptca system flushing difficulty - during prep¿ and ¿guidewire lumen obstructed- during prep¿ was confirmed via device analysis. However, the exact cause cannot be determined. During analysis the material noted inside the guidewire lumen was noted to be polyethylene, the same material that is comprised of the guidewire lumen inner body. It is likely the accordioned piece was sheared off at some point due to the interaction of the lining with a sharp object. Several factors are being considered and further investigation is required to find a definitive root cause. Therefore, based on the information available for review, it is difficult to draw a clinical conclusion between the device and the events reported as further investigation is warranted. According to the warnings in the safety information in the instructions for use, ¿flush all devices entering the vascular system with sterile heparinized saline or similar isotonic solution. Prior to use, ensure all devices have been flushed and air is removed from the system according to standard medical practice. Failure to do so could result in air entering the vascular system. ¿ the product analysis suggests that the event experienced by the customer may be associated to the manufacturing process. Therefore, a risk assessment has been initiated for further investigation.
 
Event Description
As reported, a non-cordis. 018 guidewire was unable to pass through a 2mm x 15cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter while being pre-loaded outside of the patient. Additionally, it was reported there was difficulty experienced when attempting to flush the saber pta balloon catheter during preparation. As a result, a 2mm x 20cm 150cm saber pta balloon catheter was successfully used to complete the procedure and there was no reported injury to the patient. The 2mm x 15cm 150cm saber pta balloon catheter was prepped per the instructions for use (ifu) and there were no observed kinks to the device. The non-cordis guidewire that was used was not damage in any way and was used successfully with other devices during this procedure. The target lesion was calcified and had a stenosis of 80%; however, there was no evidence of an acute angle or bifurcation present at the target site. Information regarding the target site, vessel tortuosity, and the possibility of an injectable obstruction was requested but not provided, and the device will be returned for evaluation. Addendum: product evaluation on (b)(6) 2022 revealed a piece of detached inner body polyethylene tucked inside the guide wire lumen.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSABER 2MM15CM 150
Type of DeviceCATHETER, 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 Key14238306
MDR Text Key290461830
Report Number9616099-2022-05598
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K971010
Number of Events Reported1
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
Report Date 04/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number48002015X
Device Catalogue Number48002015X
Device Lot Number82221979
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/19/2021
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: 04/28/2022 Patient Sequence Number: 1
Treatment
2MM X 20CM 150CM SABER PTA BALLOON CATHETER; V18 GUIDE WIRE (BOSTON SCIENTIFIC)
-
-