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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER035 5MM6CM 80 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION SABER035 5MM6CM 80 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 48005006N
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/08/2020
Event Type  malfunction  
Manufacturer Narrative
Complaint conclusion: as reported, the marker bands of a. 035¿ 5mm x 6cm 80 saber percutaneous transluminal angioplasty (pta) balloon catheter lacks visibility. The procedure was completed normally, but with a poor visibility of the marker bands, having a negative impact on the accuracy of the balloon placement. There was no reported patient injury. In the receiving area, the saber was not exposed to long periods of sunlight. The humidity was not controlled in this room. The product was stored there for around 2 days before it was distributed to the cath lab. At any time prior to use in the cath lab, the device was not exposed to long periods of sunlight, high temperatures or increased humidity. The balloon cover/sheath and shipping stylet were removed separately. There was no damage noted to the product¿s packaging prior to opening. There were no anomalies noted when the device was removed from its packaging. There were no kinks noted on the device in the affected region. The intended procedure was an iliac procedure. The lesion was moderately calcified. There was no vessel tortuosity. The device was not used for a chronic total occlusion (total occlusion >3 months). The device was stored and handled per the instruction for use (ifu). There was no difficulty removing the product from the hoop. There was difficulty removing the protective balloon cover. There was no difficulty removing the stylet or any of the sterile packaging components. There were no kinks nor other damages noted prior to inserting the product into the patient. The device was prepped normally (i. E. Maintain negative pressure). An indeflator inflation device was used. The same indeflator was used successfully with other devices. There was 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 was no difficulty advancing the balloon catheter through the vessel. There was no difficulty crossing the lesion. The catheter was never in an acute bend. The catheter was not torqued against resistance. The catheter was not re-shaped by the user. The product was removed intact (in one piece) from the patient. All the marker bands were accounted for after removal of the device. The device was not returned for analysis. A product history record (phr) review of lot 82198013 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿marker band-balloon catheters inadequate radiopacity, packaging/ pouch/box removal difficulty - protective balloon cover (balloon catheters) and pta/ptca system resistance/friction-outer body¿ could not be confirmed as the device was not returned for analysis. Nor were procedural images provided for review. The exact cause could not be determined. Possible causes of the reported events may include how the device was prepped, procedural factors such as fluoroscopy settings, and/or vessel characteristics. However, without the return of the device for analysis, or images of the reported inadequate radiopacity, it is not possible to draw a clinical conclusion between the device and the events reported by the customer. According to the device description in the safety information in the instructions for use ¿the cordis saber¿. 035 percutaneous transluminal angioplasty (pta) catheter is a catheter with a distal inflatable balloon. Radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. For balloon lengths 100mm or greater, the distal section will have two (2) adjacent marker bands and the proximal section will have one (1) marker band. For balloon lengths less than 100mm, the distal and proximal section will have each one (1) marker band. The catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses. Saber balloons are coated with a hydrophilic material designed to increase lubricity throughout the lifetime of the device. The radiopaque marker bands indicate the stated nominal length of the balloon. Prepare an angioplasty inflation system with a 50% solution of contrast medium in sterile saline or similar solution. ¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event. Therefore, no corrective or preventive action will be taken at this time.
 
Event Description
As reported, the marker bands of a. 035¿ 5mm x 6cm 80 saber percutaneous transluminal angioplasty (pta) balloon catheter lacks visibility. The procedure was completed normally, but with a poor visibility of the marker bands, having a negative impact on the accuracy of the balloon placement. There was no reported patient injury. In the receiving area, the saber was not exposed to long periods of sunlight. The humidity was not controlled in this room. The product was stored there for around 2 days before it was distributed to the cath lab. At any time prior to use in the cath lab, the device was not exposed to long periods of sunlight, high temperatures or increased humidity. The balloon cover/sheath and shipping stylet were removed separately. There was no damage noted to the product¿s packaging prior to opening. There were no anomalies noted when the device was removed from its packaging. There were no kinks noted on the device in the affected region. The intended procedure was an iliac procedure. The lesion was moderately calcified. There was no vessel tortuosity. The device was not used for a chronic total occlusion (total occlusion >3 months). The device was stored and handled per the instruction for use (ifu). There was no difficulty removing the product from the hoop. There was difficulty removing the protective balloon cover. There was no difficulty removing the stylet or any of the sterile packaging components. There were no kinks nor other damages noted prior to inserting the product into the patient. The device was prepped normally (i. E. Maintain negative pressure). An indeflator inflation device was used. The same indeflator was used successfully with other devices. There was 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 was no difficulty advancing the balloon catheter through the vessel. There was no difficulty crossing the lesion. The catheter was never in an acute bend. The catheter was not torqued against resistance. The catheter was not re-shaped by the user. The product was removed intact (in one piece) from the patient. All the marker bands were accounted for after removal of the device.
 
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Brand NameSABER035 5MM6CM 80
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 Key11273724
MDR Text Key230266329
Report Number9616099-2021-04233
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number48005006N
Device Catalogue Number48005006N
Device Lot Number82198013
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/06/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/28/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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