MAUDE Adverse Event Report: CORDIS CORPORATION MAXI PTA BALLOON CATHETER; PTA CATHETERS (LIT)

Catalog Number 4161540L

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 12/05/2015

Event Type  malfunction  

Manufacturer Narrative

Please note that the gender of the patient is unknown.(b)(6).This is one of two products involved with this complaint and the associated manufacturer report numbers are 9616099-2015-00673 and 9616099-2015-00674.The device is expected to be returned, however, it has not yet been received.A device history record (dhr) review and additional information are pending and will be submitted within 30 days.

Event Description

As reported, the physician was not able to remove the air completely from a 15x40mm maxi ld balloon during negative pressure which was further reported as "air kept removing from the product." it was exchanged to a 20x40mm maxi ld device; however the same issue occurred.It was exchanged for another one and the procedure was completed successfully.There was no reported patient injury.The patient's information was unknown.The target lesion was the abdominal aortic aneurysm.The lesion was not calcified and moderately tortuous.The rate of stenosis was 0%.For the procedure, a 15x40mm maxi ld pta catheter 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; however it was unknown if there was any damages noted to the inflation port.When the physician tried to remove air inside a 15x40mm maxi ld balloon catheter by a syringe during preparation, air could not be removed completely during negative pressure which was further reported as "air kept removing from the product." therefore, the physician stopped using the maxi ld and exchanged for another maxi ld catheter but the same issue occurred.The brand of syringe used and whether it was used successfully with other devices are unknown.It is unknown if there was any difficulty experienced as the syringe was connected to the device or if the same syringe was used to complete the procedure.It is unknown if the catheters were in an acute bend.Therefore the maxi ld was changed to another unknown brand.The procedure finished successfully.There was no reported patient injury.The products were not clinically used.And these will be returned for analysis.

Manufacturer Narrative

The device was returned for analysis.This is one of two products involved with this complaint and the associated manufacturer report numbers are 9616099-2015-00673 and 9616099-2015-00674.Complaint conclusion: the physician was not able to remove the air completely from a 15x40mm maxi ld balloon catheter (bc) during negative pressure which was further reported as "air kept removing from the product." it was exchanged to a 20x40mm maxi ld device; however, the same issue occurred.It was exchanged for another one and the procedure was completed successfully.There was no reported patient injury.The patient¿s information was unknown.The target lesion was the abdominal aortic aneurysm.The lesion was not calcified and moderately tortuous.The rate of stenosis was 0%.For the procedure, a 15x40mm maxi ld pta catheter 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; however it was unknown if there was any damages noted to the inflation port.When the physician tried to remove air inside a 15x40mm maxi ld balloon catheter by a syringe during preparation, air could not be removed completely during negative pressure which was further reported as "air kept removing from the product." therefore, the physician stopped using the maxi ld and exchanged for another maxi ld catheter but the same issue occurred.The brand of syringe used and whether it was used successfully with other devices are unknown.It is unknown if there was any difficulty experienced as the syringe was connected to the device or if the same syring4 was used to complete the procedure.It is unknown if the catheters were in an acute bend.Therefore the maxi ld was changed to another unknown brand.The procedure finished successfully.There was no reported patient injury.The product were returned for analysis.One non sterile maxi ld 7f 15x4 110cm bc was returned.Per visual analysis the balloon had been inflated and fully deflated.No anomalies were noted.A leak test was performed and no leakage was found.A device history record (dhr) review of lot 17125111 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon leakage-during negative prep¿ was not confirmed by analysis of the returned device as functional analysis was performed successfully.The exact cause of the reported event could not be confirmed.The device performed as intended and therefore the reported event and the dhr could not be related to the manufacturing process; therefore, no corrective/preventive action will be taken.

• Brand Name: MAXI PTA BALLOON 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: 5330022
• MDR Text Key: 34489568
• Report Number: 9616099-2015-00673
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K963000
• 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
• Report Date: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: 4161540L
• Device Lot Number: 17125111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 12/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1