MAUDE Adverse Event Report: CORDIS DE MEXICO SAVVY PTA DILATATION CATHETER; PTA CATHETERS (LIT)

Catalog Number 435200X

Device Problems Burst Container or Vessel (1074); Material Frayed (1262); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2014

Event Type  malfunction  

Event Description

During an angioplasty to the left anterior tibial, it was reported that two pta savvy balloons (2.00x10cm) burst with an encore inflation device during initial inflation.The balloons were removed intact from the patient with no difficulty.The procedure was completed with a larger 3.0 x 100 savvy and there was no adverse impact to the patient.There was no difficulty removing the products from the hoop or removing the protective balloon covers.There was no difficulty removing the stylet or any of the sterile packaging components.No kinks or other damages were noted prior to inserting the products into the patient.The devices did prep normally, maintaining negative pressure.The contrast media used is unknown.The contrast to saline ratio was 50/50.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloons through the rotating hemostatic valve or while inserting the balloons through the guide catheter.While advancing the balloon catheters through the vessel, the physician thinks that the tip of the balloon became torn while passing through stenosis; both balloons appeared to be ripped/ torn at tip.Immediate extravasations were noted upon initial inflation of both balloons.The balloon catheters kink while being used.The lesion characteristics was very calcified and had 70% stenosis.

Manufacturer Narrative

The patient's gender is unknown.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

A device history record review was performed and showed that this lot of products met all requirements per the applicable manufacturing quality plan.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 an angioplasty to the left anterior tibial, it was reported that two pta savvy balloons (2.00x10cm) burst with an encore inflation device during initial inflation.The balloons were removed intact from the patient with no difficulty.The procedure was completed with a larger 3.0 x 100 savvy and there was no adverse impact to the patient.The lesion was very calcified and had 70% stenosis.There was no difficulty removing the products from the hoop or removing the protective balloon covers.There was no difficulty removing the stylet or any of the sterile packaging components.No kinks or other damages were noted prior to inserting the products into the patient.The devices did prep normally, maintaining negative pressure.The contrast media used is unknown.The contrast to saline ratio was 50/50.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloons through the rotating hemostatic valve or while inserting the balloons through the guide catheter.While advancing the balloon catheters through the vessel, the physician thinks that the tip of the balloon became torn while passing through stenosis; both balloons appeared to be ripped/ torn at tip.Immediate extravasations were noted upon initial inflation of both balloons.The balloon catheters kinked while being used.Two non sterile catheters pta savvy 2.00x10cm 150cm were received coiled inside a plastic bag.The balloon was previously inflated and deflated in both devices.No damages were noted in the devices.Leak test was performed to both devices and a pinhole was noted in the distal section of the balloons.Sem results of the two balloons showed that the external and internal surfaces exhibited evidence of tear in the material; possibly from an unknown object coming from the external surface to the inside.This balloon leakages failure exhibited no other surface anomalies that could have caused the failure.The distal marker bands exhibited no anomalies.No damages were noted in the tips.Review of lot 16022163 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The reported balloon burst-at/below rbp was confirmed since leakage was noted in the balloon due to a pinhole during functional test.The reported distal tip damaged and body shaft kinked-bent were not confirmed since no damages were noted.The exact cause of balloon pinhole could not be determined during analysis.Based on the information available for review, vessel characteristics (heavily calcified, 70% stenosis) may have contributed to the difficulty experienced by the customer.Neither the dhr nor the product analysis suggests that the balloon burst could be related to the design and manufacturing process; therefore no actions will be taken.

• Brand Name: SAVVY PTA DILATATION CATHETER
• Type of Device: PTA CATHETERS (LIT)
• Manufacturer (Section D): CORDIS DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer Contact: cecil navajas ; miami lakes, FL 33014 ; 63138802
• MDR Report Key: 4111332
• MDR Text Key: 16859077
• Report Number: 9616099-2014-00622
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: 435200X
• Device Lot Number: 16022163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2014
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1