• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CORDIS CORPORATION SABERX PTA DILATATION CATHETER PTA CATHETERS (LIT) Back to Search Results
Catalog Number 51003015L
Device Problems Material Frayed; Torn Material; Catheter; Tip
Event Date 06/24/2016
Event Type  Malfunction  
Manufacturer Narrative

The phone number for the initial reporter/section e is: (b)(6). A review of the manufacturing documentation associated with this lot 17391633 was performed and the following was found: review of lot 17391633 revealed no anomalies during the manufacturing and inspection process. The product is available for evaluation and testing. However, the product has not been returned as of to date. Additional information will be submitted within 30 days upon receipt.

 
Event Description

As reported, the distal tip of the 155 cm. Saber 3 mm. X 15 cm. Balloon catheter (bc) was noted to be frayed as it was reaching nominal pressure during the third dilation. The product was removed from the patient. Another same size saber bc was used to complete the procedure successfully. There was no reported patient injury. The product was clinically used and it will be returned for analysis. The target lesion was a below the knee (btk). The lesion was reported to be: a 100% stenosis, not calcified and mildly tortuous. The approach was from the femoral artery. Additional information received indicated that the product was stored properly according to the instructions for use (ifu). There was no damage noted to the product packaging upon inspection prior to use. There was no reported difficulty removing the product from the packaging. The product was inspected prior to use and appeared to be normal. The product was prepped properly according to the ifu. There were no problems noted during preparation. No additional information was available regarding what additional products were used for the procedure (and if cordis products please provide the catalog/lot numbers). No information was available regarding if there were there any reported product issues with the other additional products used. It was unknown if there was any reported difficulty advancing the bc/complaint product to the intended target lesion. It was unknown if there was any other product issue noted either at the account after the procedure or prior to shipping for inspection. No additional information is available.

 
Manufacturer Narrative

Additional information received; the product was returned for inspection. Additional information will be submitted within 30 days upon receipt.

 
Manufacturer Narrative

The distal tip of the 155 cm. Saber 3 mm. X 15 cm. Balloon catheter (bc) was noted to be frayed as it was reaching nominal pressure during the third dilation. The product was removed from the patient. Another same size saber bc was used to complete the procedure successfully. There was no reported patient injury. The target lesion was a below the knee (btk). The lesion was reported to be: a 100% stenosis, not calcified and mildly tortuous. The approach was from the femoral artery. Additional information received indicated that the product was stored properly according to the instructions for use (ifu). There was no damage noted to the product packaging upon inspection prior to use. There was no reported difficulty removing the product from the packaging. The product was inspected prior to use and appeared to be normal. The product was prepped properly according to the ifu. There were no problems noted during preparation. No additional information was available regarding what additional products were used for the procedure (and if cordis products please provide the catalog/lot numbers). No information was available regarding if there were there any reported product issues with the other additional products used. It was unknown if there was any reported difficulty advancing the bc/complaint product to the intended target lesion. It was unknown if there was any other product issue noted either at the account after the procedure or prior to shipping for inspection. No additional information is available. The product was returned for analysis. One non-sterile unit of saber 3mm x 15cm 155cm bc was returned. Per visual analysis it was noted that the balloon had been inflated and deflated. No other damages were noted in the device. Per functional analysis the saber was inflated to 9 atm (nine atmospheres) and deflated with no anomalies apparent. Per microscopic analysis the tip of the device was inspected and no frayed conditions were found. A device history record (dhr) review of lot 17391633 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿distal tip - frayed/split/ torn (peripheral)¿ was not confirmed by analysis of the returned device as functional and microscopic analysis was performed successfully. The exact cause of the reported event could not be determined. According to the instructions for use ¿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. Deflate the balloon by pulling vacuum on the inflation syringe or inflation device. Apply negative pressures to the balloon for about 30 - 85 seconds until the balloon is deflated. Remove the vacuum (do not apply pressure) and carefully withdraw and remove the catheter. Note: gentle counterclockwise rotation of the balloon may ease withdrawal from the sheath or from the percutaneous entry site. If the balloon cannot be withdrawn through the sheath, withdraw the catheter and sheath as a unit. 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. ¿ the device performed as intended and there was no damage found to the distal tip therefore the reported event and the dhr could not be related to the manufacturing process; therefore, no corrective/preventive action will be taken.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSABERX 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 Key5788601
Report Number9616099-2016-00432
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 06/24/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/13/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2018
Device Catalogue Number51003015L
Device LOT Number17391633
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/03/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/29/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

-
-