MAUDE Adverse Event Report: CORDIS DE MEXICO SABER 5MM6CM 150; PTA BALLOON CATHETER

Model Number N/A

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2016

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis but the engineering report is pending.  a device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.  additional information is pending and will be submitted within 30 days upon receipt.

Event Description

During a percutaneous transluminal angioplasty (pta) shunt case, when a guide wire was inserted into a 5mm6cm 150 saber pta the guidewire penetrated between the balloon and its distal tip.Therefore the balloon catheter was replaced with a new balloon catheter.The procedure finished successfully.There was no reported patient injury.The product will be returned for analysis.  the target lesion was the shunt.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown. there was no difficulty removing the product from the hoop, no difficulty removing the protective balloon cover and no difficulty removing 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.  there was no difficulty inserting the device onto the wire.  additional procedural details were requested but are unknown.

Manufacturer Narrative

During a percutaneous transluminal angioplasty (pta) shunt case, when a guide wire was inserted into a 5mm6cm 150 saber balloon catheter (bc), the guidewire penetrated between the balloon and its distal tip.Therefore the balloon catheter was replaced with a new balloon catheter.The procedure finished successfully.There was no reported patient injury.The target lesion was the shunt.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.Additional information was received that there was no difficulty removing the product from the hoop, no difficulty removing the protective balloon cover and no difficulty removing 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.There was no difficulty inserting the device onto the wire.Additional procedural details were requested but are unknown.  one non-sterile catheter saber 5mm4cm 90 was received coiled inside a plastic bag.Per visual analysis the distal tip area presented a fractured/separation condition at.3mm.No other anomalies/damages were found on the received unit.Sem results showed that the characteristics observed on the rupture point of both sides of the tip separation leads to the same failure mode.The pattern of trail lines observed on the diameter surfaces at the rupture\separation point indicate that a mechanical cutting might be the cause of the mentioned separation.The exact kind of tool is unknown.Review of lot 17477982 revealed no anomalies during the manufacturing and inspection processes.  the reported ¿body/shaft- puncture/cut - during prep¿ was not confirmed through analysis; however, it was noted that the distal tip presented a fractured/separated condition.The exact cause of the failure reported by the customer as well as the separation of distal tip found could not be conclusively determined.However, based on the sem results, procedural factors likely contributed to the conditions reported.According to the instructions for use (ifu), ¿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.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.¿ 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.

• Brand Name: SABER 5MM6CM 150
• Type of Device: PTA BALLOON 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: cecil navajas ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6122299
• MDR Text Key: 60761315
• Report Number: 9616099-2016-00750
• 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,Followup
• Report Date: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 48005006X
• Device Lot Number: 17477982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2016
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/28/2016
• Date Manufacturer Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1