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

Model Number N/A

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).The product is available for evaluation and testing; however, it has not been received to date.Additional information will be submitted within 30 days of receipt.

Event Description

During the use of a slalom thrill to the shunt vessel (6x4 40cm 4f), it was reported that the device was delivered to the lesion and inflated.However it ruptured radially at 14 atmospheres (atm) and its distal tip separated in the left vessel.The separation occurred when the balloon was inflated and ruptured.The lesion was straight-line portion with the radial vein and there was 1mm calcified and coarctate.After that, the vessel was cut down under fluoroscopic and separated tip was retrieved surgically.The procedure was completed.The product will be returned for analysis.The patient's current status is unknown.There was no difficulty removing the product from the hoop or removing the protective balloon cover.There was 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.The device prepped normally, maintaining negative pressure.It is unknown approximately how far from the distal end did the device separate.The lesion was mildly calcified and tortuous.The rate of stenosis was unknown.The following information is unknown, if the balloon catheter have to pass through any previously implanted stents, if the balloon catheter was ever in an acute bend, the contrast media used, the contrast to saline ratio, if the same indeflator was used successfully with other devices, if there was any resistance/friction while inserting the balloon through the rotating hemostatic valve or while inserting the balloon through the guide catheter, if there was any difficulty advancing the balloon catheter through the vessel, if the balloon catheter kinked while being used, if the balloon ruptured during its initial inflation, the amount of times the balloon was inflated or the amount of times the balloon was inserted into the patient.Procedural films are not available.

Manufacturer Narrative

The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Complaint conclusion: during the use of a slalom thrill to the shunt vessel (6x4 40cm 4f), it was reported that the device was delivered to the lesion and inflated.However it ruptured radially at 14 atmospheres (atm) and its distal tip separated in the left vessel.The separation occurred when the balloon was inflated and ruptured.The lesion was straight-line portion with the radial vein and there was 1mm calcified and coarctate.After that, the vessel was cut down under fluoroscopic and separated tip was retrieved surgically.The procedure was completed.The patient¿s current status is unknown.The lesion was mildly calcified and tortuous.The rate of stenosis was unknown.There was no difficulty removing the product from the hoop or removing the protective balloon cover.There was 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.The device prepped normally, maintaining negative pressure.It is unknown approximately how far from the distal end did the device separate.The following information is unknown, if the balloon catheter have to pass through any previously implanted stents, if the balloon catheter was ever in an acute bend, the contrast media used, the contrast to saline ratio, if the same indeflator was used successfully with other devices, if there was any resistance/friction while inserting the balloon through the rotating hemostatic valve or while inserting the balloon through the guide catheter, if there was any difficulty advancing the balloon catheter through the vessel, if the balloon catheter kinked while being used, if the balloon ruptured during its initial inflation, the amount of times the balloon was inflated or the amount of times the balloon was inserted into the patient.Procedural films are not available.The product was returned for analysis.One non-sterile unit of slalom thrill 6x4 40cm 4f balloon catheter was returned.The balloon was returned burst and the middle sections of the balloon, along with the distal tip, was separated and was not returned.No other damage was observed on the device.Functional analysis was not performed due to the condition of the balloon.Per sem analysis the balloon burst separation revealed evidence of abrasion marks and scratches that could be related to the balloon separation.The internal surface did not reveal any evidence of damages.The inner body at the separation revealed evidence of elongations.Elongation is a common characteristic of pieces which were stretched or pulled until separation.A device history record (dhr) review of lot 16109440 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)¿ were 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 (mild calcification, tortuosity and an unknown rate of stenosis) may have contributed to the burst as evidenced by abrasions noted on the outer surface during analysis.Procedural or handling factors (pulling and excessive force) may have contributed to the separation as evidenced by elongations noted on the inner body associated with the separation.According to the instructions for use ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding.Balloon pressure should not exceed the rated burst pressure.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.Use only the recommended balloon inflation medium.Never use air or any gaseous medium to inflate the balloon.¿ 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: SLALOM 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: 5656586
• MDR Text Key: 45227957
• Report Number: 9616099-2016-00242
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K003159
• 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,Followup,Followup
• Report Date: 04/20/2016

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: 03/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 4396040T
• Device Lot Number: 16109440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2016
• Initial Date FDA Received: 05/16/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/26/2016; 06/16/2016
• Date Device Manufactured: 05/06/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1