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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER 5MM8CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION SABER 5MM8CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 48005008X
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/03/2021
Event Type  malfunction  
Manufacturer Narrative
Complaint conclusion: as reported, the tip of a 5mm x 8cm x 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter came off when it was loaded over a. 018¿ unknown wire. There was no reported patient injury. The product was stored as per labeling. The device was opened in a sterile field. The device was not used in a patient. The intended procedure was a superficial femoral artery (sfa) angioplasty. The device was not resterilized. There were no anomalies noted when removed from the package. There were no anomalies noted during prep. The device was not inserted through a stopcock instead of a hemostatic valve. The device did not kink in the area of separation. A new balloon was opened, and the user continued with the procedure successfully. The device was not returned for evaluation. A product history record (phr) review of lot 82205433 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The complaint reported by the customer as ¿distal tip separated¿ was not confirmed as the device was not returned for analysis. The exact cause cannot be determined. Handling of the device and procedural factors likely contributed to the reported event. However, without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and the event reported. According to the safety information in the instructions for use ¿prepare an angioplasty inflation system with a 50% solution of contrast medium in sterile saline or similar solution. Without twisting, slide the forming tube off the balloon. Prepare an angioplasty inflation system with a 50% solution of contrast medium in sterile saline or similar solution. Place the prepared catheter over a prepositioned guidewire and advance the tip to the introduction site. Note: balloon inflation should be performed with the guidewire extended beyond the catheter tip. It is strongly recommended that the guidewire, the balloon catheter, or both, remain across the lesion until the procedure is complete and the dilatation system is to be removed from the vessel. Note: to preserve the folded balloon shape during insertion and catheter manipulation, maintain a vacuum on the inflation lumen. Prior to angioplasty, the catheter should be examined to verify functionality and integrity, and ensure that its size and shape are suitable for the specific procedure for which it is to be used. Do not use if product damage is suspected or evident. Proper functioning of the catheter depends on its integrity. Care should be used when handling the catheter. Damage may result from kinking, stretching, or forceful wiping of the catheter. Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces. Always verify integrity of the catheter after removal. ¿ neither the phr review nor the product analysis suggests that the found damages could be related to the manufacturing process of the unit. Therefore, no corrective or preventive actions will be taken at this time.
 
Event Description
As reported, the tip of a 5mm x 8cm x 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter came off when it was loaded over a. 018¿ unknown wire. There was no reported patient injury. The product was stored as per labeling. The device was opened in a sterile field. The device was not used in a patient. The intended procedure was a superficial femoral artery (sfa) angioplasty. The device was not resterilized. There were no anomalies noted when removed from the package. There were no anomalies noted during prep. The device was not inserted through a stopcock instead of a hemostatic valve. The device did not kink in the area of separation. A new balloon was opened, and the user continued with the procedure successfully. The device will be returned for evaluation.
 
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Brand NameSABER 5MM8CM 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 Key12382569
MDR Text Key268780631
Report Number9616099-2021-04817
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K971010
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 08/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number48005008X
Device Catalogue Number48005008X
Device Lot Number82205433
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 Received08/04/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/21/2020
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: 08/30/2021 Patient Sequence Number: 1
Treatment
UNKNOWN 018 WIRE
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