MAUDE Adverse Event Report: CORDIS DE MEXICO SABER RX5MM15CM155; 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 05/31/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).  the device recd in two pieces with an unknown guidewire and the hub was not included.  a device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.  the engineering report is pending and will be submitted within 30 days upon receipt.

Event Description

During an ¿iso¿ case of a lesion in the left superficial femoral artery, a 5 mm 15 cm 155 length saber rx percutaneous transluminal angioplasty (pta) catheter ruptured during inflation at the proximal portion (edge) of a previously implanted stent.  the physician attempted to remove the balloon to drag it into a sheath several times but the balloon tip and the shaft separated.The separated tip was removed from the patient.Surgical treatment was performed to remove the separated distal tip of the balloon.  the tip, the separated balloon, and the distal marker were completely removed from the patient.The procedure finished successfully.  the patient has no complication and is doing well.The fragment(s) of the separated balloon will be returned for analysis.  the patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.A stent (7 x 150 smart stent) was implanted in the distal portion of the superficial femoral artery and another stent (7 x 150 non cordis stent) in the proximal region of the superficial femoral artery have been previously implanted.A contralateral approach was made when the saber catheter was inserted and inflated at the proximal portion of the stent edge.  no anomalies were confirmed prior to use.  the physician commented that the ballooning procedure was performed over a stent which previously has been implanted in the bifurcation of the superficial femoral artery and the deep femoral artery up to the common femoral artery, and that might have caused balloon rupture.  the patient is making steady progress. there was no difficulty removing the product from the hoop, no difficulty removing the protective balloon cover and no difficulty removing the stylet or any of the sterile packaging components.  the balloon was caught in a deployed stent (from the doctor¿s view).  there was resistance met while withdrawing the device into the guide catheter.

Manufacturer Narrative

During an ¿iso¿ case of a lesion in the left superficial femoral artery, a 5mm 15cm 155 length saber rx percutaneous transluminal angioplasty (pta) catheter ruptured during inflation at the proximal portion (edge) of a previously implanted stent.The physician attempted to remove the balloon to drag it into a sheath several times but the balloon was caught in the deployed stent, and the balloon tip and shaft separated.The separated tip was removed from the patient.Surgical treatment was performed to remove the separated distal tip of the balloon.The tip, the separated balloon, and the distal marker were completely removed from the patient.The procedure finished successfully.The patient has no complication and is doing well.The fragment(s) of the separated balloon will be returned for analysis.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.A stent (7x150 smart stent) was implanted in the distal portion of the superficial femoral artery and another stent (7x150 non cordis stent) in the proximal region of the superficial femoral artery have been previously implanted.A contralateral approach was made when the saber catheter was inserted and inflated at the proximal portion of the stent edge.No anomalies were confirmed prior to use.The physician commented that the ballooning procedure was performed over a stent which previously has been implanted in the bifurcation of the superficial femoral artery and the deep femoral artery up to the common femoral artery, and that might have caused balloon rupture.The patient is making steady progress.There was no difficulty removing the product from the hoop, no difficulty removing the protective balloon cover and no difficulty removing the stylet or any of the sterile packaging components.The balloon was caught in a deployed stent (from the doctor¿s view).There was resistance met while withdrawing the device into the guide catheter.The distal part of a saber rx5mm15cm155 was received inside a plastic bag separated in two sections along with an unknown guide wire.Per visual analysis, it was noted that the balloon presented a rupture/separation.Additionally the inner body was separated and also the saber body shaft was found separated.The hub and proximal section of the saber unit were not received for analysis.No other issues were found.The unit was sent to sem analysis in order to find the potential cause of the balloon rupture/separation, the saber¿s inner member/outer body shaft separation.Results showed that the external surface of the balloon presented evidence of scratches near to the balloon rupture and it¿s very likely that the same factors that caused the scratches on the balloon¿s outer surface could have also contributed to the rupture found on the received balloon.The internal surface did not present any evidence of damages.Also, the catheter body separated sections presented evidence of elongations and frayed edges.The elongations and frayed edges observed suggest that the device was induced to stretching/pulling events that exceeded the material¿s 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 the od proximal seal was found within specification.A device history record (dhr) review of the manufacturing documentation associated with lot 1741414852 revealed no anomalies during the manufacturing and inspection processes.The reported ¿balloon ¿ burst,¿ ¿pta/ptca system - separated ¿ in patient¿ and ¿pta/ptca system - withdrawal difficulty - through a previously deployed stent¿ were confirmed through analysis of the returned device.The exact cause of the balloon rupture/separation and shaft separation found could not be conclusively determined during the analysis.Based on the information available for review, lesion characteristics (although unknown) and/or procedural/handling factors (caught on the deployed stent) may have contributed to the balloon burst, withdrawal difficulty and subsequent separations as evidenced by the scratches on the balloon¿s outer surface, and the presence of elongations and frayed edges at the separated section noted 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.The reported ¿balloon ¿ burst,¿ ¿pta/ptca system - separated ¿ in patient¿ and ¿pta/ptca system - withdrawal difficulty - through a previously deployed stent¿ were confirmed through analysis of the returned device.The exact cause of the balloon rupture/separation and shaft separation found could not be conclusively determined during the analysis.Based on the information available for review, lesion characteristics (although unknown) and/or procedural/handling factors (caught on the deployed stent) may have contributed to the balloon burst, withdrawal difficulty and subsequent separations as evidenced by the scratches on the balloon¿s outer surface, and the presence of elongations and frayed edges at the separated section noted 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 RX5MM15CM155
• 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: 6659725
• MDR Text Key: 78150482
• Report Number: 9616099-2017-01189
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 51005015L
• Device Lot Number: 17414852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/31/2017
• Date Manufacturer Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2016
• 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: GUIDING SHEATH: 6 FR 45 CM DESTINATION (TERUMO)G
• Patient Outcome(s): Life Threatening; Required Intervention