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U.S. Department of Health and Human Services

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

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CORDIS CORPORATION AVIATOR PLUS PTA DILATATION CATHETER PTA CATHETERS (LIT) Back to Search Results
Catalog Number 4245515W
Device Problems Detachment Of Device Component; Catheter; Tip
Event Date 07/24/2015
Event Type  Malfunction  
Manufacturer Narrative

(b)(6). This device is available for analysis but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt.

 
Event Description

During pta of an 80% occluded lesion in the right renal artery that was not calcified and mildly tortuous, the distal tip of a. 014 5. 5x15 142cm aviator plus balloon catheter separated. The device was removed and replaced with anther balloon catheter to complete the procedure successfully. There was no reported patient injury. The product will be returned for analysis. After the lesion was crossed by a guidewire (chevalier 14 universal, fmd), the aviator plus balloon catheter was delivered and inflated at the lesion at 10atm for 30secound for pre-dilation. The physician attempted to advance the aviator plus over the guidewire for post-dilation. However the distal tip (2mm-3mm) of the balloon catheter separated (2mm-3mm). It was confirmed before inserting the balloon catheter into the sheath guide. Therefore the physician stopped using the balloon and new balloon catheter (5. 5mmײ0mm aviator plus) was instead.

 
Manufacturer Narrative

During a pta (percutaneous transluminal angioplasty) of an 80% occluded lesion in the right renal artery that was not calcified and mildly tortuous, the distal tip of a. 014¿ 5. 5x15 142cm aviator plus balloon catheter (bc) separated. The device was removed and replaced with anther balloon catheter to complete the procedure successfully. There was no reported patient injury. After the lesion was crossed by a guidewire, the aviator plus balloon catheter was delivered and inflated at the lesion at 10 atm for 30 second for pre-dilation. The physician attempted to advance the aviator plus over the guidewire for post-dilation. However the distal tip (2mm-3mm) of the balloon catheter separated (2mm-3mm). It was confirmed before inserting the balloon catheter into the sheath guide. Therefore the physician stopped using the balloon and new balloon catheter (5. 5mm×20mm aviator plus) was used instead. There were no anomalies noted when the device was removed from the package or during prep. It is unknown if the device was inserted through a stopcock instead of a hemostatic valve. The device was used in the patient but it did not separate inside the patient. The physician found the tip separation before inserting the balloon into the sheath. It is unknown if resistance was met while advancing the device or while advancing the device over the guidewire. It is also unknown if excessive torqueing was required, if the device kinked in the area of separation or if there was resistance met while withdrawing the device. Procedural films are not available. The product was returned for analysis. A non-sterile aviator plus. 014¿ 5. 5 x 15 142cm bc was returned. Per visual analysis, the balloon was partially deflated and the distal tip was damaged. Per microscopic analysis the distal tip showed a broken/separated distal tip catheter condition approximately 2-3 mm from the distal end. Elongations were observed on the distal tip separation edges. A device history record (dhr) review of lot 17037458 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿distal tip- separated - (peripheral)¿ was confirmed through analysis of the returned device. The exact cause of the separation could not be determined during analysis. Based on the information available for review, procedural factors or handling may have contributed to the burst as evidenced by elongations on the distal tip separation edges during analysis, indicative of excessive force being applied. According to the instructions for use, the user should not retract the catheter unless the balloon is fully deflated under vacuum. If resistance is met during manipulation, determine the cause of the resistance before proceeding. Prior to use, the device should be examined to verify functionality and integrity, and ensure that its size is suitable for the specific procedure. Caution: if strong resistance is met during advancement or withdrawal of the balloon catheter, discontinue movement and determine the cause of resistance before proceeding. If the cause of resistance cannot be determined, withdraw the entire system. Note: if the balloon cannot be withdrawn through the guiding catheter, withdraw the balloon catheter and guiding catheter as a single unit. 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.

 
Manufacturer Narrative

Additional details were received that there were no anomalies noted when the device was removed from the package or during prep. It is unknown if the device was inserted through a stopcock instead of a hemostatic valve. The device was used in the patient but it did not separate inside the patient. The physician found the tip separation before inserting the balloon into the sheath. It is unknown if resistance was met while advancing the device or while advancing the device over the guidewire. It is also unknown if excessive torqueing was required, if the device kinked in the area of separation or if there was resistance met while withdrawing the device. The device separated approximately 2-3mm from the distal end. The tip of the balloon separated out of the patient. Procedural films are not available. Additional information is pending and will be submitted within 30 days upon receipt.

 
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Brand NameAVIATOR PLUS 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 Key5007878
Report Number9616099-2015-00376
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type FOREIGN
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 07/27/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/17/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2017
Device Catalogue Number4245515W
Device LOT Number17037458
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/10/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/03/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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