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

Model Number UNKSABER

Device Problem Deflation Problem (1149)

Patient Problem Thrombus (2101)

Event Date 04/21/2017

Event Type  Injury  

Manufacturer Narrative

After a smart stent was deployed in the thrombotic lesion, a saber percutaneous transluminal angioplasty (pta) balloon was delivered for post dilatation. However, it took one minute to deflate the balloon halfway. The balloon was removed from the lesion without complete deflation. It was then confirmed that the prolapsed thrombus was scraped off by the balloon. There was no reported patient injury. The patient¿s information is unknown. The target lesion was the common iliac artery. The patient¿s vessel level of tortuosity and calcification are unknown. The rate of stenosis is unknown. There were no difficulties in removing the stylet or any of the sterile packaging components, the product from the hoop, or the protective balloon cover. The device prepped normally. The saber was replaced with a new non-cordis balloon and the procedure was finished successfully after 7 hours. Additional procedural details were requested but are unknown. The product was not returned for analysis. No lot number was provided therefore a device history record (dhr) review could not be generated. 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 the physician did not wait for the balloon to deflate. 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 If the balloon cannot be withdrawn through the sheath, withdraw the catheter and sheath as a unit. ¿ as no lot number was supplied a dhr could not be completed. 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.

Event Description

It was reported that after a smart stent was deployed in the thrombotic lesion, a saber percutaneous transluminal angioplasty (pta) balloon was delivered for post dilatation. However, it took one minute to deflate the balloon halfway. The balloon was removed from the lesion without complete deflation. It was then confirmed that the prolapsed thrombus was scraped off by the balloon. There was no reported patient injury. The patient¿s information was unknown. The target lesion was the common iliac artery. The patient¿s vessel level of tortuousness and calcification were unknown. The rate of stenosis was unknown. There were no difficulties in removing the stylet or any of the sterile packaging components, the product from the hoop, or the protective balloon cover. The device prepped normally. The saber was replaced with a new non-cordis balloon and the procedure was finished successfully after 7 hours. The product was clinically used and it will not be returned for analysis. Additional procedural details were requested but are unknown.

• 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 DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6576642
• MDR Text Key: 75482769
• Report Number: 9616099-2017-01110
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K971010
• 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
• Report Date: 05/18/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: UNKSABER
• Device Catalogue Number: UNKSABER
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 04/24/2017
• Event Location: No Information
• Date Manufacturer Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial