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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER 5MM20CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER 5MM20CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 48005020X
Device Problem Detachment Of Device Component (1104)
Patient Problem No Code Available (3191)
Event Date 10/24/2017
Event Type  Injury  
Manufacturer Narrative
After further review of additional information received the sections have been updated accordingly. Additional information is pending and will be submitted within 30 days upon receipt.
 
Manufacturer Narrative
After further review of additional information received the sections have been updated accordingly. The saber pta balloon catheter (bc) was dilated to 12atm (twelve atmospheres) then, the device was supposed to be taken out as usual but the balloon broke. Several attempts were made for removing the broken device (two parts). However, it didn't work out so the physician decided to use a non-cordis 4f to snare. The second part of the broken balloon could be grabbed, so the patient was punctured on the right side as well. Accessing by left side made it finally possibly to get the second part of the balloon which was separated from the catheter. There was no patient injury and the patient is doing well. The lesion was severely calcified and tortuous. Initially, a femoral approach was made a punctured in the left side of the superficial femoral artery (sfa) with a non-cordis catheter then, a 0. 018 wire was used. There were no visible signs of device/package damage prior to use. There were no anomalies noted when the device was taken out of the package. The device was not resterilized. The device was not pulled from the packaging by the hub; therefore, there was no anomalies noted at this time. The device was prepped according to instructions for use (ifu). There was no difficulty advancing the balloon catheter through the vessel. There was no difficulty tracking the device through the vessel or lesion. There were no kink/bent noted after device was removed from patient. There was no unusual force used at any time during the procedure. The product was returned for analysis. One non-sterile saber 5mm x 20cm 150cm bc was returned. Per visual analysis the balloon was received separated in two sections. An unknown snare sheath was included. No other anomalies were noted. Per sem analysis the external surface of balloon revealed evidence of scratches and abrasions marks near to the balloon rupture and it¿s very likely that the same factors that caused these damages on the balloon outer surface also contributed to the burst/rupture found on the received balloon. The internal surface did not reveal any evidence of damages. No other anomalies were found during the analysis. A product history record (phr) review of lot 17665319 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿balloon separated - in-patient¿ was confirmed through analysis of the returned device. The exact cause of the event could not be determined during analysis. Based on the information available for review, vessel characteristics (severe calcification and tortuosity) may have contributed to the burst as evidenced by abrasions noted on the outer surface during analysis. This in turn may have led to the separation as the removal of a damaged balloon catheter from a severely calcified and tortuous vessel may have caused the balloon catheter to exceed its material yield strength and separate. According to the warnings in the safety information in the instructions for use ¿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. To reduce the potential for vessel damage or the risk of dislodgement of particles it is very important that the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the lesion. The balloon dimensions are printed on the product label. The compliance table incorporated with the product shows how balloon diameter increases as pressure increases. Do not exceed the rated burst pressure recommended on the label. 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. Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath. Balloon rupture can cause vessel damage and the need for additional intervention. Use only the recommended balloon inflation medium (a 50/50 mixture by volume of contrast medium and normal saline). Never use air or any gaseous medium to inflate the balloon. ¿ according to the safety information of the instructions for use ¿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 review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.
 
Manufacturer Narrative
A review of the manufacturing documentation associated with lot (17665319) presented no issues during the manufacturing process that can be related to the reported event. (b)(4). Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, the saber pta dilation catheter was dilated (to 12atm), then, the device was supposed to be taken out as usual but the balloon broke. Several attempts were made for removing the broken device (two parts). However, it didn't work out, so the physician decided to use a non-cordis 4f to snare. The second part of the broken balloon could be grabbed, so the patient was punctured on the right side as well. Accessing by left side made it finally possibly to get the second part of the balloon which was separated from the catheter. There was no patient injury and the patient is doing well. The lesion was severely calcified and tortuous. Initially, a femoral approach was made a punctured in the left side of the superficial femoral artery (sfa) with a non-cordis co catheter, then, a 0. 0018 wire was used. There were no visible signs of device/package damage prior to use. There were no anomalies noted when the device was taken out of the package. The device was not resterilized. The device was not pulled from the packaging by the hub; therefore, there was no anomalies noted at this time. The device was prepped according to instructions for use (ifu). There was no difficulty advancing the balloon catheter through the vessel. There was no difficulty tracking the device through the vessel or lesion. There were no kink/bent noted after device was removed from patient. There was no unusual force used at any time during the procedure. The product will be returned for analysis.
 
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Brand NameSABER 5MM20CM 150
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key7069245
MDR Text Key252170495
Report Number9616099-2017-01634
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K971010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Catalogue Number48005020X
Device Lot Number17665319
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/21/2017
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: 11/29/2017 Patient Sequence Number: 1
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