MAUDE Adverse Event Report: CORDIS DE MEXICO UNKSABER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number UNKSABER

Device Problem Deflation Problem (1149)

Patient Problem Thrombosis (2100)

Event Date 04/21/2017

Event Type  Injury  

Event Description

It was reported that a saber balloon catheter was difficult to deflate.The device was removed before it completely deflated and the prolapsed thrombus was scraped off by the balloon.Therefore, the saber was replaced with a new non cordis balloon catheter and the procedure was completed successfully.There was no reported patient injury.A smart stent was deployed in the thrombotic lesion, and a saber balloon was delivered to the lesion for post dilatation.However, it took one minute to deflate the balloon half way, and the balloon was removed from the lesion without complete deflation.The procedure took 7 hours.The physician has experienced delay of other procedures due to deflation difficulty of saber balloon for three to four times before.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.The device prep normally.There were no difficulties removing the product from the hoop, the protective balloon cover, 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 product was removed intact (in one piece) from the patient.The product was clinically used and will not be returned for analysis.No other information was provided.

Manufacturer Narrative

After a smart stent was deployed in the thrombotic lesion, and a saber balloon was delivered to the lesion for post-dilatation; however, it was reported that the saber balloon catheter was difficult to deflate.It took one minute to deflate the balloon half way.The device was removed before it completely deflated and the prolapsed thrombus was scraped off by the balloon.Therefore, the saber was replaced with a new non cordis balloon catheter and the procedure was completed 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.The device prep normally.There were no difficulties removing the product from the hoop, the protective balloon cover, 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 product was removed intact (in one piece) from the patient.The procedure took 7 hours.No other information was provided.The device was not returned for analysis.A device history record (dhr) review could not be conducted as a lot number was not provided.The reported ¿balloon deflation difficulty - partial or slow¿ and the subsequent thrombus removal with the balloon could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Based on the limited information available for review, procedural/handling factors may have contributed to the reported events.According to the instructions for use, ¿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.¿ without a lot number to conduct a dhr review, it is not possible to determine if the reported failure could be related to the manufacturing process.Therefore no corrective and preventive actions will be taken at this time.

• Brand Name: UNKSABER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, tp ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6581090
• MDR Text Key: 75607313
• Report Number: 9616099-2017-01111
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKSABER
• 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: 05/23/2017
• 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