MAUDE Adverse Event Report: CORDIS DE MEXICO SABER 6MM25CM 90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48006025S

Device Problems Burst Container or Vessel (1074); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2017

Event Type  malfunction  

Manufacturer Narrative

A device history record (dhr) review of lot 17046123 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.This device is available for analysis but the engineering report is not yet available. however, it will be submitted within 30 days upon receipt.This is one of 2 products involved with the reported event.The associated manufacturer report number is 9616099-2017-00992.

Event Description

It was reported that a saber balloon burst at nominal pressure.The balloon catheter was glued to the wire and therefore the physician had to remove the balloon catheter together with the wire. when it was pulled out through a non-cordis catheter sheath introducer (csi), the balloon catheter separated into two pieces.The physician exchanged the csi, the guidewire and the balloon.The new saber balloon chosen to treat the lesion also burst and was discarded after use.There was no issue removing the balloon from the vessel.There was no reported patient injury.The target lesion was the superficial femoral artery (sfa).The lesion was severely calcified.The devices were stored and handled according to the instructions for use (ifu).The pta balloon catheters were prepared per the instructions for use (ifu).The devices prepped normally (i.E.Maintained negative pressure).There was no difficulty removing the products from the hoop, removing the protective balloon covers, or removing the stylet or any of the sterile packaging components.The contrast to saline ratio was 50/50.There were no kinks or other damages noted prior to inserting the product the products into the patient.An indeflator was used as the inflation device and it was used successfully with other devices.The first balloon was inserted over a non-cordis guidewire.No guide catheter was used.There was no resistance/friction while inserting the balloons through the rotating hemostatic valve.There was no difficulty advancing the balloon catheters through the vessel.There was no difficulty crossing the lesion.Each balloon was inflated only once prior to the bursts.The balloons maintained pressure prior to the bursts.The second balloon catheter that burst was removed intact from the patient.At the end of the procedure, a non-cordis stent was implanted successfully.Additional procedural details were requested but are unknown.

Manufacturer Narrative

A saber balloon burst at nominal pressure.The balloon catheter (bc) was glued to the wire and therefore the physician had to remove the balloon catheter together with the wire.When it was pulled out through a non-cordis catheter sheath introducer (csi), the balloon catheter separated into two pieces.The physician exchanged the csi, the guidewire and the balloon.The new saber balloon chosen to treat the lesion also burst and was discarded after use.There was no issue removing the balloon from the vessel.There was no reported patient injury.The target lesion was the superficial femoral artery (sfa).The lesion was severely calcified.The devices were stored and handled according to the instructions for use (ifu).The pta balloon catheters were prepared per the ifu.The devices prepped normally (i.E.Maintained negative pressure).There was no difficulty removing the products from the hoop, removing the protective balloon covers, or removing the stylet or any of the sterile packaging components.The contrast to saline ratio was 50/50.There were no kinks or other damages noted prior to inserting the product the products into the patient.An indeflator was used as the inflation device and it was used successfully with other devices.The first balloon was inserted over a non-cordis guidewire.No guide catheter was used.There was no resistance/friction while inserting the balloons through the rotating hemostatic valve.There was no difficulty advancing the balloon catheters through the vessel.There was no difficulty crossing the lesion.Each balloon was inflated only once prior to the bursts.The balloons maintained pressure prior to the bursts.The second balloon catheter that burst was removed intact from the patient.At the end of the procedure, a non-cordis stent was implanted successfully.Additional procedural details were requested but are unknown.One non-sterile catheter saber 5mm x 10cm 90cm bc was returned for analysis.Per visual analysis the inner member was returned separated along with an unknown cannula.Balloon had been inflated.The marker bands were not present on the analyzed sample.Functional analysis not be performed due the condition of the device.Per microscopic analysis an accordion condition and a cut were noted on the inner member, and an axial cut was noted in the balloon.Per sem analysis the internal surface did not reveal any evidence of damage.However, the external surface revealed evidence of abrasion and scratched marks adjacent to the balloon ruptured areas and it is very likely that the same factors that caused the abrasions and scratch marks on the balloon outer surface also contributed to the balloon axial burst and radial separation found.Additionally, the separated inner lumen surface revealed evidence of elongations at the surrounding areas of the separation.The elongation noted could be related to an application of a force that induced a material deformation until rupture.It is noteworthy to mention that the marker bands were not present on the analyzed sample.No other anomalies were noted during analysis.A device history record (dhr) review of lot 17046123 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst-at/below rbp¿ and ¿pta/ptca system separated - during use¿ 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, vessel characteristics (severe calcification) may have contributed to the burst as evidenced by abrasions noted on the outer surface during analysis, whilst excessive force applied to the catheter on removal through the csi as evidenced by elongations and deformations noted during analysis.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 at this time.

• Brand Name: SABER 6MM25CM 90
• 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: cecil navajas ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6431479
• MDR Text Key: 70775338
• Report Number: 9616099-2017-00993
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 04/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: 48006025S
• Device Catalogue Number: 48006025S
• Device Lot Number: 17046123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/24/2017
• Date Manufacturer Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2014
• 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
• Treatment: SABER BALLOON