MAUDE Adverse Event Report: CORDIS DE MEXICO SABER 8MM4CM 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 No Consequences Or Impact To Patient (2199)

Event Date 05/19/2017

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 a fistuloplasty case a 8 mm 4 cm 90 saber percutaneous transluminal angioplasty (pta) catheter burst and split itself on the wire so the distal wire and balloon remnant needed snaring from the patient. the physician indicated the balloon burst because they "over-inflated it trying to dilate a resistant lesion ¿ it then snagged on the sheath during withdrawal and split."  the device will be returned for analysis.

Manufacturer Narrative

Boston scientific v18 str tip 0.018 x 200cm, cordis avanti sheath 6f and 8f 11cm, ge omnipaque 300 and boston scientific encore syringe.Additional procedural details were also received that the patient is doing well post procedure.The lesion was a right mid cephalic vein stenosis (fistula) with no calcification or vessel tortuosity.  it was not a chonic total occlusion lesion. there were no anomalies noted when removed from the package and no anomalies noted during prep. the access site was the right cephalic vein.  the device was not inserted through a stopcock instead of a hemostatic valve.  it prepped normally. the contrast media was ge omnipaque 300 at a 50:50 contrast to saline ratio.A boston scientific encore indeflator/syringe was used. the balloon inflated normally and the maximum inflation pressure was 14 atmospheres (atm), 2 above rated burst pressure (rbp). the procedure was completed with snaring of balloon.  patient is being rebooked for redo with cutting balloon.Procedural films were requested but are not available.The engineering report is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

During a fistuloplasty case, an 8mm4cm 90cm saber percutaneous transluminal angioplasty (pta) catheter burst at 2 atmopspheres above rated burst pressure (rpb) and split itself on the wire so the distal wire and balloon remnant needed snaring from the patient.The physician indicated the balloon burst because they "over-inflated it trying to dilate a resistant lesion ¿ it then snagged on the sheath during withdrawal and split." the patient is doing well post procedure.The lesion was a right mid cephalic vein stenosis (fistula) with no calcification or vessel tortuosity.It was not a chronic total occlusion lesion.There were no anomalies noted when removed from the package and no anomalies noted during prep.The access site was the right cephalic vein.The device was not inserted through a stopcock instead of a hemostatic valve.It prepped normally.The contrast media was ge omnipaque 300 at a 50:50 contrast to saline ratio.A boston scientific encore indeflator/syringe was used.The balloon inflated normally and the maximum inflation pressure was 14 atmospheres (atm), 2 above rbp.The procedure was completed with snaring of balloon and the patient is being rebooked for redo with cutting balloon.Procedural films were requested but are not available.One non sterile saber 8mm4cm 90 was received inside a plastic bag.Per visual analysis, it was noticed that the balloon presented a rupture/separation at the balloon¿s middle section.Additionally, the inner body was found also separated.No other issues were found.The unit was sent to sem analysis and results showed that the external surface of balloon presented evidence of abrasions and scratch marks near to the balloon rupture.It¿s very likely that the same factors that caused the scratch marks on the balloon¿s outer surface could have also contributed to the rupture found on the received balloon.The internal surface did not presented any evidence of damages.The inner body separated section presented evidence of elongations.The elongations observed suggest that the device was induced to stretching/pulling events that exceeded the material yield strength prior to the separation.No other issues were noted during sem analysis.No other anomalies were found during the analysis.Dimensional analysis for od proximal seal was performed and was found within specification.A device history record (dhr) review of the manufacturing documentation associated with lot 17326494 revealed no anomalies during the manufacturing and inspection processes.The reported ¿balloon burst above rbp¿, ¿balloon separated - in-patient¿ and ¿pta/ptca system - withdrawal difficulty - through guide/sheath¿ was confirmed through analysis of the returned device.The cause of the balloon rupture/separation and inner body and body shaft separation found could not be conclusively determined during the analysis.Based on the limited information available for review, vessel characteristics (resistant lesion), and handling factors (inflation above rbp and snagging during withdrawal) most likely led to the burst, withdrawal difficulty and separation reported as evidenced by the scratch marks and abrasions noted on the balloon, and the presence of elongations noted on the body of the catheter during sem analysis.According to the instructions for use (ifu), which is not intended as a mitigation, ¿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.¿ also stated in the ifu, ¿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 at this time.

• Brand Name: SABER 8MM4CM 90 PTA CATHETER
• 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: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6643130
• MDR Text Key: 77634679
• Report Number: 9616099-2017-01172
• 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,consum
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/06/2017

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: 08/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 48008004S
• Device Lot Number: 17326494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/24/2017
• Initial Date Manufacturer Received: 05/24/2017
• Initial Date FDA Received: 06/15/2017
• Supplement Dates Manufacturer Received: Not provided; 06/28/2017
• Supplement Dates FDA Received: 06/20/2017; 07/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2015
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR