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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL UNKSABER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL UNKSABER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number UNKSABER
Device Problems Burst Container or Vessel (1074); Detachment Of Device Component (1104)
Patient Problem No Code Available (3191)
Event Date 03/20/2018
Event Type  Injury  
Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt. (b)(4).
 
Event Description
As reported, an unknown saber pta balloon catheter burst during a procedure at fourteen (14 atm) atmosphere pressure, when they took the balloon catheter out it was realised that the balloon material and marker bands had been left inside the patient. After several attempts to retrieve the parts that broken off from the balloon, the patient then had to be blue lighted to another hospital to go to surgery to have them removed under surgery. The target lesion was the proximal superficial femoral artery. The vessel level of calcification was mild. The vessel level of tortuosity was none. The vessel level of stenosis was 50%. The device was not used for a total chronic occlusion (cto) lesion. The device was stored and handled per the instructions for use (ifu). There was no difficulty removing the stylet or any of the sterile packaging components. There was no difficulty removing the product from the hoop. There was no difficulty removing the protective balloon cover. The device was prepped according to instructions for use (ifu). The device was prep normally. There were no anomalies noted during or after the device was prepped. A non-cordis contrast media used in the procedure. The contras to saline ratio was 50/50. A non-cordis indeflator was used in the procedure. The same indeflator was used successfully with other devices. The maximum inflation pressure was 14 atm. The balloon had been successfully inflated up to 14 atm on a lesion slightly proximal to the index lesion. The inflation time was 2 minutes. The balloon was deflated completely and advanced without resistance to the index lesion approx 4 cm distally. On inflation of the balloon, just before pressure of 14 atm was reached, the balloon burst. There was no difficulty tracking the catheter through the vessel or lesion. The catheter was not torqued against resistance. The catheter was not re-shaped by the user. After the device was removed it was noted that the distal tip, balloon material and radiopaque markers were missing. There was no kink/bend noted in the area of separation. There was no unusual force used at any time during the procedure. The patient needed emergency surgery to remove foreign material from superficial femoral artery.
 
Manufacturer Narrative
As reported, an unknown saber pta balloon catheter burst during a procedure at fourteen (14 atm) atmosphere pressures. When they took the balloon catheter out, it was realized that the balloon material and marker bands had been left inside the patient. After several attempts to retrieve the parts that broke off from the balloon, the patient then had to be blue-lighted to another hospital to go to surgery to have them removed. The target lesion was the proximal superficial femoral artery. The vessel level of calcification was mild with no tortuosity. The stenosis was 50%. The device was not used for a total chronic occlusion (cto) lesion. The device was stored and handled per the instructions for use (ifu). There was no difficulty removing the stylet or any of the sterile packaging components. There was no difficulty removing the product from the hoop. There was no difficulty removing the protective balloon cover. The device was prepped according to instructions for use (ifu). The device was prep normally. There were no anomalies noted during or after the device was prepped. A non-cordis contrast media used in the procedure. The contrast-to-saline ratio was 50/50. A non-cordis indeflator was used in the procedure. The same indeflator was used successfully with other devices. The maximum inflation pressure was 14 atm. The balloon had been successfully inflated up to 14 atm on a lesion slightly proximal to the index lesion. The inflation time was 2 minutes. The balloon was deflated completely and advanced without resistance to the index lesion approx. 4 cm distally. On inflation of the balloon, just before pressure of 14 atm was reached, the balloon burst. There was no difficulty tracking the catheter through the vessel or lesion. The catheter was not torqued against resistance. The catheter was not re-shaped by the user. After the device was removed, it was noted that the distal tip, balloon material, and radiopaque markers were missing. There was no kink/bend noted in the area of separation. There was no unusual force used at any time during the procedure. The patient needed emergency surgery to remove foreign material from superficial femoral artery. The product was not returned for analysis. A device history record (dhr) review could not be conducted as a lot number was not provided. The reported ¿balloon burst at/below rbp,¿ ¿balloon separated in patient,¿ and ¿marker band dislodged in patient¿ could not be confirmed as the device was not returned for analysis. The exact cause of the burst, separation and dislodged marker band could not be determined. Based on the limited information available for review, lesion characteristics (mild calcification) and handling factors may have contributed to the reported events since calcified/resistant lesions can damage a balloon. As warned in the instructions for use, which is not intended as a mitigation, ¿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. 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. 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. 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. ¿ without a lot number to conduct a dhr review, it is not possible to determine if the reported failure could be related to the manufacturing process. Therefore no corrective and preventive actions will be taken at this time.
 
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Brand NameUNKSABER
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
MDR Report Key7440908
MDR Text Key105840613
Report Number9616099-2018-02061
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K971010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup,Followup
Report Date 11/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKSABER
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/27/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/07/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/18/2018 Patient Sequence Number: 1
Treatment
CONTRAS MEDIA (OMNIPAQUE); INFLATION DEVICE (COOK); CONTRAS MEDIA (OMNIPAQUE); INFLATION DEVICE (COOK)
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