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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 48003004X
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)(4). This device is not available for testing and evaluation. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

During an unspecified interventional procedure, a saber percutaneous transluminal angioplasty (pta) ruptured during dilatation. Therefore the balloon was changed to another balloon (same size). The procedure was finished successfully. There was no reported patient injury. The product will not be returned for analysis. The target lesion was the left superficial femoral artery (cto). The rate of stenosis was unknown. A contralateral approach was made. The saber balloon catheter was used for back-up and a guidewire was approached to the lesion. The back-up was not enough and the handle ability of the guidewire got low quality. Therefore the balloon was inflated at the place the balloon passed and the guiding catheter was delivered to the ballooning place. After that, the guidewire was crossed the lesion (cto) and the physician tried to inflated the balloon at the remaining occluded part. However it ruptured during dilatation. The procedure was for the left superficial femoral artery (cto). The access site is unknown. It is unknown what location was initially dilated with the saber. 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 prepped normally. The brand of contrast and the contrast to saline ratio are unknown. The brand of inflation device was used is also unknown. It is unknown if the same indeflator was used successfully with other devices. It is unknown if there was any resistance/friction while inserting the balloon through the rotating hemostatic valve. It is unknown if there was any difficulty advancing the balloon catheter through the vessel and if there was any difficulty crossing the lesion. It is also unknown if the catheter was ever in an acute bend. It is unknown if the balloon inflated normally. The maximum inflation pressure is unknown. It is unknown if the balloon catheter kinked while being used. It is unknown if the balloon catheter removed easily from the vessel and from the other devices.

 
Manufacturer Narrative

During an unspecified interventional procedure, a saber percutaneous transluminal angioplasty (pta) balloon catheter (bc) ruptured during dilatation. Therefore the balloon was changed to another balloon (same size). The procedure was finished successfully. There was no reported patient injury. The target lesion was the left superficial femoral artery. The lesion was a chronic total occlusion (cto). The rate of stenosis was unknown. A contralateral approach was made. The saber balloon catheter was used for back-up and a guidewire was approached to the lesion. The back-up was not enough and the handling ability of the guidewire was of low quality. Therefore the balloon was inflated at the place the balloon passed and the guiding catheter was delivered to the ballooning place. After that, the guidewire was crossed the lesion (cto) and the physician tried to inflated the balloon at the remaining occluded part. However it ruptured during dilatation. The procedure was for the left superficial femoral artery (cto). The access site is unknown. It is unknown what location was initially dilated with the saber. 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 prepped normally. The brand of contrast and the contrast to saline ratio are unknown. The brand of inflation device was used is also unknown. It is unknown if the same indeflator was used successfully with other devices. It is unknown if there was any resistance/friction while inserting the balloon through the rotating hemostatic valve. It is unknown if there was any difficulty advancing the balloon catheter through the vessel and if there was any difficulty crossing the lesion. It is also unknown if the catheter was ever in an acute bend. It is unknown if the balloon inflated normally. The maximum inflation pressure is unknown. It is unknown if the balloon catheter kinked while being used. It is unknown if the balloon catheter removed easily from the vessel and from the other devices. The product was not returned for analysis. A device history record (dhr) review of lot 17178309 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 a chronic total occlusion 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.

 
Manufacturer Narrative

A revised review of lot 17178309 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint. No additional information is available and no further reports will be forthcoming.

 
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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 Key5293279
MDR Text Key33429090
Report Number9616099-2015-00644
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 COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 11/25/2015
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 Number48003004X
Device LOT Number17178309
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 Received01/19/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/06/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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