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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL MAXI LD 7F 16X4 80CM; DILATOR, ESOPHAGEAL
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CORDIS CASHEL MAXI LD 7F 16X4 80CM; DILATOR, ESOPHAGEAL Back to Search Results
Model Number 4171640S
Device Problem Burst Container or Vessel (1074)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/03/2019
Event Type  malfunction  
Manufacturer Narrative
This is one of three products involved with the reported event.The medical device reporting reference number for the other events are 9616099-2019-03045 and 9616099-2019-03046.The device was not returned for analysis.Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
During use, three maxi ld balloon catheters burst at one atmosphere (1 atm) during the initial inflation.There was no patient injury.A competitor's balloon was used to complete the procedure.There were no difficulty inflating the balloon during prep.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.A competitor's contrast media and inflation device was used with a one to four ratio.The inflation device was successfully used with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or the guide catheter.The product removed intact (in one piece) from the patient.No other information was provided.
 
Manufacturer Narrative
During use, three maxi ld balloon catheters burst at one atmosphere (1atm) during the initial inflation.There was no patient injury.A competitor's balloon was used to complete the procedure.There were no difficulties inflating the balloons during prep.There were no difficulties removing the products from the hoop, the protective balloon covers, the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the products into the patient.A competitor's contrast media and inflation device was used with a one to four ratio.The inflation device was successfully used with other devices.There was no resistance/friction while inserting the balloons through the rotating hemostatic valve or the guide catheter.The products were removed intact (in one piece) from the patient.No other information was provided.The product was not returned for analysis.A product history record (phr) review of lot 82161181 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst-at/below rbp¿ could not be confirmed as the devices were not returned for analysis.The exact cause could not be determined.Vessel characteristics, although unknown, may have contributed to the reported event as calcification is known to cause damage to balloon catheters.According to the safety information in the instructions for use ¿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.Carefully advance the catheter through a sheath or through the percutaneous entry site.Note: gentle counterclockwise rotation of the balloon may ease introduction through the sheath or percutaneous entry site.Note: perform all further catheter manipulations under fluoroscopy.Carefully advance the catheter to the selected site.Caution: if strong resistance is met during advancement or withdrawal of the catheter, discontinue movement and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the entire system.Note: the rated burst pressure is printed on the package label.In vitro testing has shown that with 95% confidence, 99.9% of the balloons will not burst at or below the rated pressure.Balloons should not be inflated in excess of the rated burst pressure.¿ neither the phr nor the very limited information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
 
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Brand Name
MAXI LD 7F 16X4 80CM
Type of Device
DILATOR, ESOPHAGEAL
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, tipperary 0000
EI  0000
MDR Report Key8746800
MDR Text Key150854279
Report Number9616099-2019-03047
Device Sequence Number1
Product Code KNQ
UDI-Device Identifier20705032002568
UDI-Public20705032002568
Combination Product (y/n)N
PMA/PMN Number
K023907
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 07/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2020
Device Model Number4171640S
Device Catalogue Number4171640S
Device Lot Number82161181
Was Device Available for Evaluation? No
Date Manufacturer Received07/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNKNOWN.
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