MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER; PTA CATHETERS (LIT)

Catalog Number 4400410X

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4)  please note the event date is unknown.Additional information will be submitted within 30 days of receipt.

Event Description

During the use of a powerflex pro balloon catheter, it was reported that the balloon burst during inflation.There was no report of patient injury.

Manufacturer Narrative

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 the use of a powerflex pro balloon catheter, it was reported that the balloon burst during inflation.There was no report of patient injury.The product was returned for analysis.One non-sterile powerflex pro 4mm x 10cm 135cm balloon catheter was returned.Per visual analysis, no anomalies were noted on the device.A leak test was performed and no anomalies were found.A device history record (dhr) review of lot 17247090 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst (peripheral)¿ 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: POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY 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: 5302414
• MDR Text Key: 33641476
• Report Number: 9616099-2015-00654
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K112797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2015

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: 06/30/2017
• Device Catalogue Number: 4400410X
• Device Lot Number: 17067536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2015
• Initial Date FDA Received: 12/16/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/18/2016; 01/27/2016
• Date Device Manufactured: 08/07/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1