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

Catalog Number 4400602X

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be submitted within 30 days of receipt.

Event Description

During the use of a powerflex pro balloon, it was reported that the physician inflated the balloon and realized that the balloon was ruptured.There was no patient injury reported.The product will be returned for analysis.

Manufacturer Narrative

During the use of a powerflex pro balloon catheter (bc), it was reported that the physician inflated the balloon and realized that the balloon was ruptured.There was no patient injury reported.Multiple attempts to gather additional information have been made and have been unsuccessful.The product was not returned for analysis.A device history record (dhr) review of lot 17305606 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)¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics and procedural factors are unknown.Neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken.

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 (bc), it was reported that the physician inflated the balloon and realized that the balloon was ruptured.There was no patient injury reported.The product was returned for analysis.One non sterile powerflex pro 6mm x 2cm 135cm bc was returned.Per visual analysis the balloon appeared to have been inflated and deflated.No other anomalies were observed in the device.A leak test could not be performed since a leakage was noted in the distal section of the balloon due to a pinhole.Per sem analysis neither the external nor the internal surface of the balloon near to the pinhole, revealed any evidence of damages that could be related to the balloon pin hole.However, the borders of the slit appear to have been caused by a sharp object.The distal marker band did not appear to have been damaged.A device history record (dhr) review of lot 17305606 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 through analysis of the returned device, as the pressure applied to the balloon was not supplied.However a pinhole was noted during analysis.The exact cause could not be determined.Vessel characteristics are unknown but may have contributed to the reported event as the balloon appears to have been pierced by a sharp object.Neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; 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: 5318029
• MDR Text Key: 34148497
• Report Number: 9616099-2015-00670
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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,Followup
• Report Date: 12/04/2015

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: 07/31/2018
• Device Catalogue Number: 4400602X
• Device Lot Number: 17305606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2015
• Initial Date FDA Received: 12/22/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/26/2016; 03/01/2016; 03/04/2016
• Date Device Manufactured: 08/21/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1