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

Catalog Number 48003015X

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2015

Event Type  malfunction  

Manufacturer Narrative

(describe event or problem): the saber pta was inserted into the patient.It is unknown if there was resistance/friction as the device was inserted into the patient; or if there was difficulty experienced as the device was advanced to and across the lesion.When delivered to the lesion, the balloon was inflated.However, it ruptured at nominal pressure.It was unknown if the catheter was ever in an acute bend or kink during use.It is unknown if the balloon initially inflated normally before rupture.It is unknown if the balloon catheter was removed easily from the patient; however, it was removed intact (in one piece).The balloon was changed to another 4x150mm saber pta.The procedure finished successfully.There was no reported patient injury.The product was clinically used.And it will be returned for analysis.Please note that the gender of the patient is unknown.Concomitant devices: guidewire (treasure, st.Jude medical) and sheath introducer (6fr parent, medikit).(b)(6) the device is expected to be returned for analysis; however, it has not yet been received by the decontamination lab.A device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the balloon of a saber pta catheter ruptured at nominal pressure.It was removed and another saber pta catheter was used to complete the procedure.There was no reported patient injury.The patient's information was unknown.The target lesion was the right superficial femoral artery.The lesion was mildly calcified and not tortuous.The rate of stenosis was 100% (cto).For the procedure, a 3x150mm saber pta was opened.There was no difficulty removing the product from the hoop or removing the balloon cover/stylet.There were no kinks or damages noted to the device prior to use.The device was prepped normally with no anomalies noted during prep.The contrast media, contrast ratio, and brand indeflator were unknown.A contralateral approach was made.A non-cordis guidewire (unknown if there was difficulty crossing the lesion) with a non-cordis 6f sheath introducer crossed the lesion but intravascular ultrasound (ivus) could not cross.

Manufacturer Narrative

The device has been returned for analysis.The engineering report is not available; however, it will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: the balloon of a saber pta catheter ruptured at nominal pressure.It was removed and another saber pta catheter was used to complete the procedure.There was no reported patient injury.The patient¿s information was unknown.The target lesion was the right superficial femoral artery.The lesion was mildly calcified and not tortuous.The rate of stenosis was a 100% cto (chronic total occlusion).For the procedure, a 3x150mm saber pta was opened.There was no difficulty removing the product from the hoop or removing the balloon cover/stylet.There were no kinks or damages noted to the device prior to use.The device was prepped normally with no anomalies noted during prep.The contrast media, contrast ratio, and brand indeflator were unknown.A contralateral approach was made.A non-cordis guidewire (unknown if there was difficulty crossing the lesion) with a non-cordis 6f sheath introducer crossed the lesion but intravascular ultrasound (ivus) could not cross.The saber pta was inserted into the patient.It is unknown if there was resistance/friction as the device was inserted into the patient; or if there was difficulty experienced as the device was advanced to and across the lesion.When delivered to the lesion, the balloon was inflated.However, it ruptured at nominal pressure.It was unknown if the catheter was ever in an acute bend or kink during use.It is unknown if the balloon initially inflated normally before rupture.It is unknown if the balloon catheter was removed easily from the patient; however, it was removed intact (in one piece).The balloon was changed to another 4x150mm saber pta.The procedure finished successfully.There was no reported patient injury.The product was returned for analysis.A non-sterile unit of saber 3mm x 15cm 150cm balloon catheter was returned.Per visual analysis the balloon had been inflated and deflated.Two kink conditions were observed on the body at 21 cm and 46 cm from the distal tip section.No another damages were noted.Functional analysis was performed and a 0.018¿ guide wire (lab sample) was advanced through the guidewire lumen successfully.A leak test was performed and a pin hole was noted on the balloon proximal section.Per sem analysis the external surface revealed evidence of scratches that could be related to the balloon pin hole.The internal surface and proximal marker bands did not presented any evidence of damages.No other anomalies were found during the analysis.A device history record (dhr) review of lot 17238607 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)¿ was confirmed through analysis of the returned device.The exact cause of the burst could not be determined during analysis.Based on the information available for review, vessel characteristics (mild calcification and rate of stenosis of 100%) may have contributed to the burst as evidenced by abrasions noted on the outer surface during analysis.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: 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: 5332710
• MDR Text Key: 34610751
• Report Number: 9616099-2015-00678
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 48003015X
• Device Lot Number: 17238607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1