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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER 3MM2CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER 3MM2CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 48003002X
Device Problem Material Puncture/Hole (1504)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/08/2020
Event Type  malfunction  
Manufacturer Narrative
An unknown wire could not cross a 3mm x 2cm saber 150 percutaneous transluminal angioplasty (pta). There was no reported patient injury. The device appeared normal when taken from its packaging. There was no difficulty experienced when removing the balloon catheter from the packaging. The product was stored, handled and inspected as per instructions for use (ifu). There was no difficulty flushing the balloon catheter with saline. A non-cordis guidewire was used. The malfunction occurred in patient. The wire and catheter crossed acute bends in the vessel to proceed in the procedure. The catheter did not advance totally over the wire. The same non-cordis guidewire was used with the new device. The lumen was properly flushed. The wire was flushed and/or wiped down prior to attempting to load the device onto it. The device was flushed every time prior to loading the balloon onto the guidewire. The device was loaded from distal to proximal. Other additional procedural details were requested but were unknown. The product was returned for analysis. One non-sterile saber 3mm x 2cm 150 was received coiled inside a plastic bag. Per visual analysis no damages or anomalies were observed. A guidewire lab sample was inserted through the guidewire lumen. No obstruction was noted inside the guidewire lumen; however, the guidewire protruded outside the guidewire lumen. It appears that a guidewire punctured through the guidewire lumen before receiving it for its analysis. A product history record (phr) review of lot 17700746 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿guidewire lumen obstructed¿ was not confirmed via device analysis. However, a secondary failure of ¿body/shaft-puncture/cut¿ was confirmed due to the lumen puncture observed on the unit during analysis. However, the exact cause of the damage could not be confirmed. It seems apparent that a guidewire punctured through the guidewire lumen catheter resulting in damage due to a sharp object or mechanical damage. Due to the nature of the damage it is likely procedural factors contributed to the events reported. Forceful handling of the balloon catheter can result in damages such as the elongations observed, inserting a stiff guidewire repeatedly into a lumen may result in the rupture noted to the lumen of the guidewire. Extreme care must be taken when using these devices in the patient vasculature. According to the safety information in the instructions for use ¿when the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum. If resistance is met during manipulation, determine the cause of resistance before proceeding. If resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected. 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 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, an unknown wire could not cross a 3mm x 2cm saber 150 percutaneous transluminal angioplasty (pta). During fal analysis it was noted that a guidewire punctured through the guidewire lumen. There was no reported patient injury. The device looked normal when taken from its packaging. There was no difficulty experienced when removing the balloon catheter from the packaging. The product was stored, handled and inspected as per instructions for use (ifu). There was no difficulty flushing the balloon catheter with saline. A non-cordis guidewire was used. The malfunction occurred in patient. The wire and catheter crossed acute bends in the vessel to proceed in the procedure. The catheter did not advance totally over the wire. The same non-cordis guidewire was used with the new device. The lumen was properly flushed. The wire was flushed and/or wiped down prior to attempting to load the device onto it. The device was flushed every time prior to loading the balloon onto the guidewire. The device was loaded from distal to proximal. The device will be returned for analysis. Other additional procedural details were requested but were unknown.
 
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Brand NameSABER 3MM2CM 150
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, tipperary 0000
EI 0000
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, tipperary, 0000
EI 0000
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key9842603
MDR Text Key200010324
Report Number9616099-2020-03566
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K971010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 03/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2020
Device Model Number48003002X
Device Catalogue Number48003002X
Device Lot Number17700746
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/27/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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