MAUDE Adverse Event Report: CORDIS DE MEXICO SABER 4MM10CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 48004010X

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2017

Event Type  malfunction  

Manufacturer Narrative

When the customer was prepping the balloon, it was noticed that the tip was damaged.There was also a tip separation noted during prep.They switched the catheter out for another balloon and completed the procedure.The original balloon wasn¿t used in the patient.There was no reported patient injury.The device was stored and handled per the instructions for use (ifu).There were no anomalies noted to the package.There were no difficulties removing the stylet or any of the sterile packaging components, the product from the hoop, or the protective balloon cover.A non-sterile saber 4mm x 10cm 150cm balloon catheter was returned for analysis.Per visual analysis seven kinked areas were noted, that are located at 16cm, 20cm, 44cm, 68cm, 90cm, 113cm, and 137cm from the distal tip end.The distal tip shows a partial separation condition.No other damages or anomalies were noted.Per sem analysis the separated sections at the distal tip revealed elongations and frayed edges.These characteristics are indicative of an application of a tension force that induced the separation.No other issues were noted.A device history record (dhr) review of lot 17622063 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿distal tip damaged - during prep¿ and ¿distal tip separated - during prep¿ were confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.Based on the information available for review, procedural or handling factors may have contributed to the event as evidenced by the kinking on the shaft and the elongations at the separation indicative of the application excessive force noted during analysis.According to the safety information in the instructions for use ¿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.¿ neither the dhr review, the procedure films 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 at this time.

Event Description

As reported, when the customer was prepping the balloon it was noticed that the tip was damaged.There was also a tip separation noted during prep.They switched the catheter out for another balloon and completed the procedure.The original balloon wasn¿t used in the patient.There was no reported patient injury.The device was stored and handled per the instructions for use (ifu).There were no anomalies noted to the package.There were no difficulties removing the stylet or any of the sterile packaging components, the product from the hoop, or the protective balloon cover.

• Brand Name: SABER 4MM10CM 150
• 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: 6772636
• MDR Text Key: 82048467
• Report Number: 9616099-2017-01300
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 48004010X
• Device Lot Number: 17622063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2017
• Initial Date FDA Received: 08/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2016
• 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