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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 48002002S
Device Problems Balloon; Burst Container or Vessel ; Material Frayed; Torn Material; Catheter
Event Date 04/21/2016
Event Type  Malfunction  
Manufacturer Narrative

Please note that the gender of the patient is unknown. Concomitant devices: 6f short sheath ; 6f brite tip guiding catheter; and chevalier universal guidewire, fmd. Phone: (b)(6). The device was received for analysis, but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt. A device history record (dhr) review was conducted and the product met quality requirements for product acceptance. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

As reported, the pressure of a saber 2x20mm 90cm pta catheter did not increase and was confirmed to have ruptured under fluoroscopy. A sleek pta catheter was used to complete the procedure. There was no reported patient injury. The device will be returned for analysis. The patient's information was unknown. The target lesion was the bk. The lesion was mildly calcified and tortuous. The rate of stenosis was unknown. There was no difficulty removing the saber from the hoop or removing the balloon cover/stylet. There were no kinks or damages noted to the device prior to use. The device was prepped normally with no anomalies noted during prep. The contrast media, contrast ratio, and brand indeflation device were unknown. An ipsilateral contralateral approach was made with a short sheath (6f) and a 6f brite tip guiding catheter. After a non-cordis guidewire was crossed the lesion (it is unknown if it crossed without difficulty), the balloon was delivered and inflated. It is unknown if there was resistance/friction as the device was inserted into the patient; or if there was difficulty experienced as the device was advanced to and across the lesion. However the pressure did not increase and was confirmed balloon ruptured under fluoroscopic. It was unknown if the catheter was ever in an acute bend or kink during use. It is unknown if the balloon initially inflated normally before rupture or what the maximum pressure was. It is unknown if the balloon catheter was removed easily from the patient; however, it was removed intact (in one piece). The balloon was removed from the patient and it was inflated outside then the leakage of media was observed from the shaft front of balloon. The balloon was changed to another new sleek balloon. The procedure was finished successfully. There was no reported patient injury. The product was clinically used.

 
Manufacturer Narrative

(b)(4). Complaint conclusion: the pressure of a saber 2x20mm 90cm pta balloon catheter (bc) did not increase and was confirmed to have ruptured under fluoroscopy. A sleek pta catheter was used to complete the procedure. There was no reported patient injury. The procedure was finished successfully. The patient¿s information is unknown. The target lesion was below the knee (btk). The lesion was mildly calcified and tortuous. The rate of stenosis was unknown. There was no difficulty removing the saber from the hoop or removing the balloon cover/stylet. There were no kinks or damages noted to the device prior to use. The device was prepped normally with no anomalies noted during prep. The contrast media, contrast ratio, and brand indeflation device were unknown. An ipsilateral contralateral approach was made with a short sheath (6f) and a 6f guiding catheter. After a non-cordis guidewire was crossed the lesion (it is unknown if it crossed without difficulty), the balloon was delivered and inflated. It is unknown if there was resistance/friction as the device was inserted into the patient; or if there was difficulty experienced as the device was advanced to and across the lesion. However the pressure did not increase and was confirmed balloon ruptured under fluoroscopy. It was unknown if the catheter was ever in an acute bend or kink during use. It is unknown if the balloon initially inflated normally before rupture or what the maximum pressure was. It is unknown if the balloon catheter was removed easily from the patient; however, it was removed intact (in one piece). The balloon was removed from the patient and it was inflated outside then the leakage of media was observed from the shaft front of balloon. The balloon was changed to another new sleek balloon. The device was returned for analysis. One non-sterile unit of saber 2mm x 2cm 90cm bc was returned. Per visual analysis the balloon appeared to have been inflated and deflated. No other anomalies were noted. Per functional analysis a leak test was performed and a leakage was observed in the outer body during test. Per sem analysis neither the external nor the internal outer body surfaces presented evidence of scratched or abrasion marks that could be related to the slit on the outer body. However, it seems that the mentioned slit might be caused by an unknown sharp object. A device history record (dhr) review of lot 17097255 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿balloon burst (peripheral)¿ was not confirmed through analysis of the returned device. However ¿body/shaft frayed/split/torn - (peripheral)¿ 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 (mild calcification, tortuosity and an unknown rate of stenosis) or procedural or handling factors may have contributed to the event as it appears the slit may have been caused by an unknown sharp object. According to the instructions for use ¿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 dhr 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.

 
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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
  32580
7863133880
MDR Report Key5651331
Report Number9616099-2016-00238
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 04/21/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/12/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2017
Device Catalogue Number48002002S
Device LOT Number17097255
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/29/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/27/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/25/2014
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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