MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 6MM4CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4400604X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the balloon of a 6mmx4cm 135 powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter (bc) burst in the superficial femoral artery (sfa) and could not be operated.There was no reported patient injury.The device will be returned for evaluation.
Additional Manufacturer Narrative
The balloon of a 6mm x 4cm 135 powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter (bc) burst in the superficial femoral artery (sfa) and could not be operated.There was no reported patient injury.Additional procedural details were requested but are unknown.The product was returned for analysis.A non-sterile powerflex pro 6mm x 4cm 135 was received for analysis coiled inside a plastic bag.Per visual analysis, the balloon appears to have been previously inflated.The unit was thoroughly inspected at naked eye and no other anomalies were observed.Per functional analysis, balloon inflation test was performed.The balloon was inflated as expected, neither a leakage nor a burst was observed on the balloon.A product history record (phr) review of lot 17724342 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ was not confirmed by analysis of the returned device.The exact cause of the reported event could not be confirmed.The device performed as intended during functional analysis and therefore the reported event could not be confirmed.With the limited amount of information provided regarding procedural factors and vessel characteristics, it is difficult to draw a clinical conclusion between the device and the event reported.However, it is likely procedural factors and handling of the device contributed to the event reported by the customer.According to the instructions for use, which is not intended as a mitigation of risk, ¿1.Attach a 3-way stopcock to the inflation port, which is marked ¿balloon¿.2.Attach a partially filled syringe with heparinized saline to the stopcock, open the stopcock to the balloon and induce negative pressure.3.Hold the syringe and proximal end of the catheter above the distal end of the catheter, and hold the balloon vertically with the balloon tip pointing down.4.While maintaining negative pressure close the stopcock to the inflation port.Remove the syringe and purge the air.5.To ensure air contained in the balloon and inflation lumen is removed, apply negative pressure twice as instructed and repeat steps 2-4.6.Without twisting, slide the forming tube off the balloon.7.Prepare an angioplasty inflation system with a 50% solution of contrast medium in sterile saline or similar solution.8.Purge the air from the inflation device.9.Connect the inflation device to the 3-way stopcock that is connected to the catheter inflation port, open the stopcock to the catheter and slowly fill the inflation lumen and the balloon will slowly fill with diluted contrast medium.Caution: do not apply positive or negative pressure to the balloon at this time.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

• Brand Name: POWERFLEXPRO 6MM4CM 135
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 9571983
• Report Number: 9616099-2020-03463
• Device Sequence Number: 438868
• Product Code: LIT
• UDI-Device Identifier: 20705032059524
• UDI-Public: 20705032059524
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K112797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

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: 09/30/2020
• Device Model Number: 4400604X
• Device Catalogue Number: 4400604X
• Device Lot Number: 17724342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1