MAUDE Adverse Event Report: CORDIS CORPORATION SABERX PTA DILATATION CATHETER; PTA CATHETERS (LIT)

Catalog Number 51008002L

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).A review of the manufacturing documentation associated with lot 17284789 revealed no anomalies during the manufacturing and inspection processes.The product is available for evaluation and testing.However, the product has not been returned as of to date.Additional information will be submitted within 30 days upon receipt.

Event Description

As reported, the 155 cm.Saber 8 mm.X 2 cm.Balloon catheter (bc) was inflated at the target lesion and ruptured at four atmospheres (4 atm.).The product was then removed from the patient and it was confirmed by angiography that the distal tip had separated and remained in the patient's vessel.Attempts were made to retrieve the separated distal tip using a thrombotic catheter and goose neck snares but were unsuccessful.Finally the separated piece was compressed to the vessel using an unknown stent.There was no reported patient injury.The product was clinically used and it will be returned for analysis.The target lesion was the common iliac artery.The lesion was reported to be: a 90% stenosis, heavily calcified and tortuous.Additional information received indicated that the separated piece was compressed to the vessel using a non-cordis stent.It was not specified if it was a covered or uncovered stent.Procedural films are not available.The patient did not experience an adverse event due to the reported event/product issue.It was not known if the patient was symptomatic as a result of the reported event.It is not known if the patient is scheduled for any type of follow-up exam due to the reported event.There was no reported difficulty removing the product from the hoop.There was no reported difficulty removing the protective balloon cover, 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.The device prepped normally (i.E.Maintained negative pressure).The following information was unknown: what contrast media are you using (brand and manufacturer); what was the contrast to saline ratio; what type and brand of inflation device was used (indeflator/syringe); was the same indeflator used successfully with other devices; was there any resistance/friction while inserting the balloon through the rotating hemostatic valve; was there any resistance/friction while inserting the balloon through the guide catheter; was there difficulty advancing the balloon catheter through the vessel; was there difficulty crossing the lesion; was the catheter ever in an acute bend; was the balloon catheter removed easily from the patient, vessel, etc.No additional information is available.

Manufacturer Narrative

Additional information: the product was returned for inspection on 04/06/2016.Additional information will be submitted within 30 days upon receipt.

Manufacturer Narrative

The 155 cm.Saber 8 mm.X 2 cm.Balloon catheter (bc) was inflated at the target lesion and ruptured at four atmospheres (4 atm.).The product was then removed from the patient and it was confirmed by angiography that the distal tip had separated and remained in the patient¿s vessel.Attempts were made to retrieve the separated distal tip using a thrombotic catheter and goose neck snares but were unsuccessful.Finally the separated piece was compressed to the vessel using an unknown stent.There was no reported patient injury.The target lesion was the common iliac artery.The lesion was reported to be: a 90% stenosis, heavily calcified and tortuous.Additional information received indicated that the separated piece was compressed to the vessel using a non-cordis stent.It was not specified if it was a covered or uncovered stent.Procedural films are not available.The patient did not experience an adverse event due to the reported event/product issue.It was not known if the patient was symptomatic as a result of the reported event.It is not known if the patient is scheduled for any type of follow-up exam due to the reported event.There was no reported difficulty removing the product from the hoop.There was no reported difficulty removing the protective balloon cover, 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.The device prepped normally (i.E.Maintained negative pressure).The following information was unknown: what contrast media are you using (brand and manufacturer); what was the contrast to saline ratio; what type and brand of inflation device was used (indeflator/syringe); was the same indeflator used successfully with other devices; was there any resistance/friction while inserting the balloon through the rotating hemostatic valve; was there any resistance/friction while inserting the balloon through the guide catheter; was there difficulty advancing the balloon catheter through the vessel; was there difficulty crossing the lesion; was the catheter ever in an acute bend; was the balloon catheter removed easily from the patient, vessel, etc.No additional information is available.The product was returned for analysis.One non sterile catheter saber 8mm x 2cm 155cm bc was returned.Per visual analysis a balloon separation was noted.The distal end of the balloon was not returned for analysis.The body shaft did not appear damaged.No other visual anomalies were noted.Per functional analysis a leak test could not be performed due to the condition of the returned balloon.Per sem analysis the external surface revealed evidence of scratch marks that could be related to the balloon burst.The internal surface did not reveal any evidence of damage.No other anomalies were found during the analysis.A device history record (dhr) review of lot 17284789 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 (peripheral)¿ and ¿distal tip separated-in patient (peripheral)¿ was confirmed through analysis 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 (heavy calcification and tortuosity and a rate of stenosis of 90%) may have contributed to the burst and resulting distal tip separation as evidenced by abrasions noted on the outer surface during analysis.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.To reduce the potential for vessel damage or the risk of dislodgement of particles it is very important that the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the lesion.The balloon dimensions are printed on the product label.The compliance table incorporated with the product shows how balloon diameter increases as pressure increases.Do not exceed the rated burst pressure recommended on the label.The rated burst pressure is based on the results of in vitro testing.At least 99.9% of the balloons (with a 95% confidence) will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over-pressurization.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.Balloon rupture can cause vessel damage and the need for additional intervention.Use only the recommended balloon inflation medium (a 50/50 mixture by volume of contrast medium and normal saline).Never use air or any gaseous medium to inflate the balloon.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, 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: SABERX PTA DILATATION CATHETER
• Type of Device: PTA CATHETERS (LIT)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5540937
• MDR Text Key: 41643794
• Report Number: 9616099-2016-00161
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 51008002L
• Device Lot Number: 17284789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention