MAUDE Adverse Event Report: CORDIS DE MEXICO SABER 6MM4CM 90; PTA CATHETER

Model Number N/A

Device Problems Burst Container or Vessel (1074); Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/25/2016

Event Type  Injury  

Manufacturer Narrative

The device was returned 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 an angiography case with very severe calcified sfa, a 6 mm 4 cm 90 saber percutaneous transluminal angioplasty (pta) balloon burst at 12 atmospheres after numerous balloon inflations previously from distal end of occlusion to proximal and when used for the remaining proximal stenosis near the sheath entry.When inflating the balloon they noticed it burst at 12 (rbp is 16).  at this point they removed it with little resistance and initially threw the balloon away.  the leg was then screened and the team was surprised to see a marker band from the balloon still showing inside the patient.  the wire was still through this part of the balloon shaft that had broken off and they then managed to pull it back through the sheath, using quite a bit of strength (it is thought that this may be when the distal part of the balloon was stretched.

Manufacturer Narrative

During an angiography case with very severe calcified superficial femoral artery (sfa), a 6mm x 4cm 90cm saber percutaneous transluminal angioplasty (pta) balloon burst at 12 atmospheres (atm) after numerous balloon inflations previously from the distal end of the occlusion to the proximal end and when used for the remaining proximal stenosis near the sheath entry.When inflating the balloon they noticed it burst at 12atm (rated burst pressure is 16atm).  at this point they removed it with little resistance and initially threw the balloon away.The leg was then screened and the team was surprised to see a marker band from the balloon still showing inside the patient.The wire was still through this part of the balloon shaft that had broken off and they then managed to pull it back through the sheath, using quite a bit of strength.It is thought that this may be when the distal part of the balloon was stretched.The product was returned for analysis. a non-sterile unit of saber 6mm x 4cm 90cm balloon catheter was returned.Per visual analysis the inner member (distal section) was separated from the catheter.A radial burst was observed at 4mm from the proximal seal.The part of the balloon missing was not returned.Functional analysis could not be performed due the condition of the device.Per microscopic analysis a radial burst was noted at 4mm from the proximal seal and elongations and accordion conditions were noted on the inner member at the separation.Per sem analysis evidence of plastic deformation and elongations at the balloon rupture edges were noted.These conditions were also noted on the inner member separation.  these characteristics are related to the application of a tension force that likely induced the separation.The internal surface did not reveal any evidence of damage.The exact cause of the balloon burst could not be conclusively determined.A device history record (dhr) review of lot 17308752 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¿, ¿distal tip/ separated - in-patient¿ and ¿pta/ptca system/ withdrawal difficulty¿ were confirmed through analysis and the condition of the returned device.The exact cause of the events could not be determined during analysis.Based on the information available for review, vessel characteristics (although unknown) and procedural and handling factors may have contributed to the events as evidenced by plastic deformation and elongations at the balloon rupture edges noted on the device during analysis, indicative of excessive tension force being applied to the device.According to the instructions for use ¿if resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.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.

• Brand Name: SABER 6MM4CM 90
• Type of Device: PTA 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: 6186714
• MDR Text Key: 62752577
• Report Number: 9616099-2016-00797
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 48006004S
• Device Lot Number: 17308752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2016
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/28/2016
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention