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

Catalog Number 48006015S

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant devices: stent: smart control, cordis replacing pta: saber pta catheter (b)(4).(b)(6).Complaint conclusion: the balloon would not expand as the pressure was raised.It was removed from the patient and another saber with different size was used.There was no reported patient injury.The patient was a male but his age was unknown.The intended procedure was a pta (percutaneous transluminal angioplasty).The target lesion was a left superficial artery.The lesion was mildly calcified and moderately tortuous.The rate of stenosis was 90%.After the smart control stent was placed in the target lesion, a saber pta balloon catheter (bc) was delivered for post-dilation and was attempted to inflate.However, even if the pressure rose, a scale did not go up without expansion of the balloon.Therefore it was removed from the patient and was confirmed the balloon was not ruptured.The saber pta catheter was exchanged for another saber (different size) and the procedure finished successfully.There was no reported patient injury.It is unknown if there was any difficulty removing the product from the hoop or removing the cover/stylet.There were no kinks or damages noted to the device prior to patient use.The device was prepped normally with no anomalies noted.Contrast and indeflator information was unknown.It is unknown if there was any difficulty advancing the guidewire or the balloon catheter into the patient and through the target lesion.There was no leakage noted as the user started to increase pressure.It is unknown if the device was kinked or in an acute bend.It is unknown if the balloon catheter was removed easily.The product was removed intact from the patient.The product was returned for analysis.One non sterile saber 6mm x 15cm 90cm bc was returned.The balloon appears to have been inflated.No anomalies were observed in the returned device.During functional analysis, water was injected through the luer hub (inflation port) and a leakage was observed from the thru-port (guide wire port).Per microscopic analysis the leakage was caused by a puncture on the inner body located distal to the hub.A device history record (dhr) review of lot 17034726 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon - inflation difficulty-unable to inflate¿ and ¿body/shaft - puncture/cut (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 (mild calcification, moderate tortuosity and a rate of stenosis of 90%) may have contributed to the event.Neither the dhr review nor the product analysis suggests that the burst experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken.

Event Description

As reported, the balloon would not expand as the pressure was raised.It was removed from the patient and another saber with different size was used.There was no reported patient injury.The patient was a male but his age was unknown.The intended procedure was a pta.The target lesion was a left superficial artery.The lesion was mildly calcified and moderately tortuous.The rate of stenosis was 90%.After the smart control stent was placed in the target lesion, a saber pta catheter was delivered for post-dilation and was attempted to inflate.However, even if the pressure rose, a scale did not go up without expansion of the balloon.Therefore it was removed from the patient and was confirmed the balloon was not ruptured.The saber pta catheter was exchanged for another saber (different size) and the procedure finished successfully.There was no reported patient injury.The product was clinically used.And it will be returned for analysis.Addendum aug 6, 2015: during functional analysis of the returned product, when water was injected by the luer hub (inflation port) a leakage was observed coming through the thru-port (guide wire port).The unit was analyzed by the pet under microscope and it was detected that the leakage was caused due to a by damage (puncture) on the inner body located distal to the hub.Additional information received indicated that it is unknown if there was any difficulty removing the product from the hoop or removing the cover/stylet.There were no kinks or damages noted to the device prior to patient use.The device was prepped normally with no anomalies noted.Contrast and indeflator information was unknown.It is unknown if there was any difficulty advancing the guidewire or the balloon catheter into the patient and through the target lesion.There was no leakage noted as the user started to increase pressure.It is unknown if the device was kinked or in an acute bend.It is unknown if the balloon catheter was removed easily.The product was removed intact from the patient.

Manufacturer Narrative

Complaint conclusion: the balloon would not expand as the pressure was raised.It was removed from the patient and another saber with different size was used.There was no reported patient injury.The patient was a male but his age was unknown.The intended procedure was a pta (percutaneous transluminal angioplasty).The target lesion was a left superficial artery.The lesion was mildly calcified and moderately tortuous.The rate of stenosis was 90%.After the smart control stent was placed in the target lesion, a saber pta balloon catheter (bc) was delivered for post-dilation and was attempted to inflate.However, even if the pressure rose, a scale did not go up without expansion of the balloon.Therefore, it was removed from the patient and was confirmed the balloon was not ruptured.The saber pta catheter was exchanged for another saber (different size) and the procedure finished successfully.There was no reported patient injury.It is unknown if there was any difficulty removing the product from the hoop or removing the cover/stylet.There were no kinks or damages noted to the device prior to patient use.The device was prepped normally with no anomalies noted.Contrast and indeflator information was unknown.It is unknown if there was any difficulty advancing the guidewire or the balloon catheter into the patient and through the target lesion.There was no leakage noted as the user started to increase pressure.It is unknown if the device was kinked or in an acute bend.It is unknown if the balloon catheter was removed easily.The product was removed intact from the patient.The product was returned for analysis.One non sterile saber 6mm x 15cm 90cm bc was returned.The balloon appears to have been inflated.No anomalies were observed in the returned device.During functional analysis, water was injected through the luer hub (inflation port) and a leakage was observed from the thru-port (guide wire port).Per microscopic analysis the leakage was caused by a puncture on the inner body located distal to the hub.A device history record (dhr) review of lot 17034726 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon - inflation difficulty-unable to inflate¿ and ¿body/shaft - puncture/cut (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 (mild calcification, moderate tortuosity and a rate of stenosis of 90%) may have contributed to the event.Neither the dhr review nor the product analysis suggests that the burst experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken.

• Brand Name: SABER 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: 5010025
• MDR Text Key: 25625931
• Report Number: 9616099-2015-00377
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Report Date: 08/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: 48006015S
• Device Lot Number: 17034726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1