MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 12MM2CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	4401202S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter (bc) (12mm x 2cm) was inserted and inflated after a non-cordis 6mm x 4cm bc was inflated, however the powerflex pro ruptured at eight atmospheres.No patient injury was reported.This was a shunt case.The lesion was the left subclavian vein which had stenosis.An approach was made from the left brachial part with a non-cordis 7 french sheath.A non-cordis guidewire crossed the lesion.After the powerflex pro ruptured, it was replaced with a new non-cordis 10mm x 4cm bc and the procedure was completed.The product was not returned for analysis.A product history record (phr) review of lot 17393949 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¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of stenosis may have contributed to the reported event.According to the warnings in the safety information in the instructions for use ¿prior to angioplasty, the catheter should be examined to verify functionality and integrity, and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Do not use if product damage is suspected or evident.To reduce the potential for vessel damage or the risk of dislodgement of particles it is very important that the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the lesion.The balloon dimensions are printed on the product label.The compliance table incorporated with the product shows how balloon diameter increases as pressure increases.Do not exceed the rated burst pressure recommended on the label.The rated burst pressure is based on the results of in vitro testing.(b)(4).Use of a pressure monitoring device is recommended to prevent over-pressurization.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.Balloon rupture can cause vessel damage and the need for additional intervention.Use only the recommended balloon inflation medium (a 50/50 mixture by volume of contrast medium and normal saline).Never use air or any gaseous medium to inflate the balloon.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
Event or Problem Description
As reported, the 12mm x 2cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter (bc) was inserted and inflated after a non-cordis 6mmx4cm bc was inflated, however the powerflex pro ruptured at eight atmospheres.No patient injury was reported.This was a shunt case.The lesion was the left subclavian vein which had stenosis.An approach was made from the left brachial part with a non-cordis 7f sheath.A non-cordis guidewire crossed the lesion.After the powerflex pro ruptured, it was replaced with a new non-cordis 10mmx4cm bc and the procedure was completed.The device has been discarded.

• Brand Name: POWERFLEXPRO 12MM2CM 80
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 8271703
• Report Number: 9616099-2019-02667
• Device Sequence Number: 2055915
• Product Code: LIT
• UDI-Device Identifier: 20705032060131
• UDI-Public: 20705032060131
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 4401202S
• Device Lot Number: 17393949
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/28/2018
• Initial Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1