MAUDE Adverse Event Report: CORDIS DE MEXICO UNKNOWN SABER PTA CATHETER

Model Number N/A

Device Problem Deflation Problem (1149)

Patient Problem Embolism (1829)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Please note that device reported is a saber pta catheter and for which the catalog and lot numbers are not currently available.  if obtained, a follow up report will be submitted within 30 days upon receipt. additional information is pending and will be submitted 30 days.

Event Description

During a percutaneous transluminal angioplasty procedure (pta) with stenting of a thrombotic lesion in the common iliac artery, a 6 mm 6 cm 155 saber rx pta catheter was used to post dilate an implanted smart lesion but the balloon was removed from the lesion without complete deflation.  it was also confirmed that prolapsed thrombus from the lesion being treated was scraped off by the balloon.  therefore it was replaced with a new non cordis balloon catheter.The procedure took 7 hours.The procedure finished successfully.There was no reported patient injury.The product will not be returned for analysis.  the target lesion was the common iliac artery.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.  a smart stent was deployed in the thrombotic lesion, and a saber pta was delivered to the lesion for a post dilatation. additional procedural details were requested but are unknown.

Manufacturer Narrative

During a percutaneous transluminal angioplasty procedure (pta) with stenting of a thrombotic lesion in the common iliac artery, a 6 mm x 6 cm 155 cm saber rx pta catheter was used to post dilate an implanted smart stent however, the balloon was removed from the lesion without complete deflation.It was confirmed that a prolapsed thrombus from the lesion being treated was scraped off by the balloon.It was replaced with a new non cordis balloon catheter.The procedure took 7 hours.The procedure finished successfully.There was no reported patient injury.The target lesion was the common iliac artery.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.Additional procedural details were requested but are unknown.The product was not returned for analysis.Additionally, as the sterile lot number was not available, a device history record (dhr) review could not be performed.The reported ¿balloon deflation difficulty - partial or slow¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Procedural factors may have contributed to the reported event as evidenced by the report in the event description that the balloon was removed prior to complete deflation.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.¿ the limited information available does not suggest a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: UNKNOWN SABER PTA CATHETER
• Type of Device: PTA CATHETER
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, GA 33014
• MDR Report Key: 6575384
• MDR Text Key: 75450115
• Report Number: 9616099-2017-01105
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKSABER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/24/2017
• Date Manufacturer Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention