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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER PTA DILATATION CATHETER PTA CATHETERS (LIT)

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CORDIS CORPORATION SABER PTA DILATATION CATHETER PTA CATHETERS (LIT) Back to Search Results
Catalog Number 48003004S
Device Problem Burst Container or Vessel (1074)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/19/2015
Event Type  Malfunction  
Manufacturer Narrative

(b)(6). The product is not available for evaluation and testing. Additional information will be submitted within 30 days of receipt.

 
Event Description

During the use of a saber balloon catheter to the superficial femoral artery, it was reported that the guidewire could not cross the lesion easily then the balloon was inflated at passing the guidewire. However, the balloon ruptured at 8 atmospheres (atm). Therefore the balloon was removed from he patient intact and another one was used. The procedure finished successfully and there was no patient injury reported. There was no problem with a saber balloon visually when it was taken out from its pouch. There was no difficulty removing the product from the hoop or removing the protective balloon cover. There was no difficulty removing 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 device was prepped normally, maintaining negative pressure. The following information is unknown, the contrast media used, the contrast to saline ratio, the type/brand of inflation device used, if there was any resistance/friction while inserting the balloon through the rotating hemostatic valve or while inserting the balloon through the guide catheter. It is unknown if the balloon catheter kink while being used, if the balloon ruptured during its initial inflation, the amount times the balloon was inflated and the amount of times the balloon was inserted into the patient. The lesion was heavily calcified and mildly tortuous. The rate of stenosis was 100%. The product will not be returned for analysis.

 
Manufacturer Narrative

Complaint conclusion: during the use of a saber balloon catheter to the superficial femoral artery, it was reported that the guidewire could not cross the lesion easily then the balloon was inflated after passing the guidewire. However, the balloon ruptured at 8 atm (eight atmospheres). Therefore the balloon was removed from the patient intact and another one was used. The procedure finished successfully and there was no patient injury reported. The lesion was heavily calcified and mildly tortuous. The rate of stenosis was 100%. There was no problem with a saber balloon visually when it was taken out from its pouch. There was no difficulty removing the product from the hoop or removing the protective balloon cover. There was no difficulty removing 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 device was prepped normally, maintaining negative pressure. The following information is unknown, the contrast media used, the contrast to saline ratio, the type/brand of inflation device used, if there was any resistance/friction while inserting the balloon through the rotating hemostatic valve or while inserting the balloon through the guide catheter. It is unknown if the balloon catheter kink while being used, if the balloon ruptured during its initial inflation, the amount times the balloon was inflated and the amount of times the balloon was inserted into the patient. The product was not returned for analysis. A device history record (dhr) review of lot 17173388 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 (peripheral)¿ could not be confirmed as the device was not returned for analysis. The exact cause could not be determined. Vessel characteristics of heavy calcification, mild tortuosity and a rate of stenosis of 100% may have contributed to the reported event. 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.

 
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Brand NameSABER PTA DILATATION CATHETER
Type of DevicePTA CATHETERS (LIT)
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL
Manufacturer Contact
cecil navajas
circuito interior norte #1820
juarez chihuahua 32580
MX   32580
7863133880
MDR Report Key5294549
MDR Text Key33429135
Report Number9616099-2015-00647
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK971010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/19/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/14/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2017
Device Catalogue Number48003004S
Device LOT Number17173388
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/05/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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