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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER 3MM4CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER 3MM4CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 48003004X
Device Problems Balloon; Burst Container or Vessel ; Physical Resistance; Difficult to Advance; Catheter
Event Date 07/07/2017
Event Type  Malfunction  
Manufacturer Narrative

It was reported that there was resistance felt advancing a saber balloon catheter to the lesion and through the guiding catheter. The saber balloon ruptured at its nominal pressure. Therefore the balloon catheter was replaced with a new unknown balloon catheter and the procedure completed successfully. There was no reported patient injury. The target lesion was the superficial femoral artery. The patient¿s vessel was not tortuous and moderately calcified. The rate of stenosis was 100 % chronic total occlusion (cto). A contralateral approach was made and a saber balloon was inserted for back-up, however there was resistance felt while advancing to the lesion. When it was inflated as a pre-dilatation, it ruptured. The device was prep normally. There were no difficulties removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components. There were no kinks or other damages noted prior to inserting the product the product into the patient. The product was removed intact (in one piece) from the patient. The device was not returned for analysis. A device history record (dhr) review of lot 17094144 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 tracking difficulty,¿ ¿pta/ptca system resistance/friction-outer body,¿ and ¿balloon burst - at/below rbp¿ could not be confirmed as the device was not returned for analysis. The exact cause of the events reported could not be determined. Based on the limited information available, vessel characteristics likely contributed to the tracking difficulty and resistance/friction reported. Difficulty tracking a product through an anatomical structure is a known procedural occurrence. This type of difficulty occurring during the clinical use of the device is usually addressed by modification in technique or substitution with another device. Tracking difficulty is most commonly related to the patient¿s anatomy, vessel characteristics, operator¿s technique and appropriate device selection. Interference or friction between devices, (including all catheters, wires, sheath introducers, balloon/sds catheters) whether between one or multiple manufacturers product lines, is a known occurrence. If resistance is encountered the system should be withdrawn together as one unit to prevent injury. This is a common practice during procedures and is stated in product¿s ifu. Based on the limited information available for review, lesion characteristics (moderately calcified cto) and procedural factors (difficulty tracking to the lesion) likely contributed to the reported balloon burst as calcification/resistant lesions may cause damage to a balloon. According to the instructions for use, which is not intended as a mitigation, ¿the rated burst pressure is based on the results of in vitro testing. At least 99. 9% of the balloons (with a 95% confidence) will not burst at or below their rated burst pressure. Use of a pressure monitoring device is recommended to prevent over-pressurization. Do not exceed the rated burst pressure recommended on the label. Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used. ¿ neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event. Therefore, no corrective/preventive action will be taken at this time.

 
Event Description

It was reported that there was resistance felt advancing a saber balloon catheter to the lesion and through the guiding catheter. The saber balloon ruptured at its nominal pressure. Therefore the balloon catheter was replaced with a new unknown balloon catheter and the procedure completed successfully. There was no reported patient injury. A contralateral approach was made and a saber balloon was inserted for back-up, however there was resistance felt while advancing to the lesion. When it was inflated as a pre-dilatation, it ruptured. The target lesion was the superficial femoral artery. The patient¿s vessel was not tortuous and moderately calcified. The rate of stenosis was 100 % (cto). The device was prep normally. There were no difficulties removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components. There were no kinks or other damages noted prior to inserting the product the product into the patient. The product was removed intact (in one piece) from the patient.  the product was clinically used and will not be returned for analysis.

 
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Brand NameSABER 3MM4CM 150
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, tipperary 32575
EI  32575
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, tipperary
EI 
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes , FL 33014
MDR Report Key6757448
Report Number9616099-2017-01281
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 08/01/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/01/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2017
Device MODEL Number48003004X
Device Catalogue Number48003004X
Device LOT Number17094144
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date07/10/2017
Event Location No Information
Date Manufacturer Received07/10/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/12/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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