MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 6MM10CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4400610S
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the internal light of the 6mm x 10cm x 80 powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter (bc) was altered.There was no reported patient injury.The device is expected to be returned for evaluation.
Additional Manufacturer Narrative
This device was received for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
The internal light of the 6mm x 10cm x 80 powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter (bc) was altered.There was no reported patient injury.The device is expected to be returned for evaluation.The device was stored and handled per the instructions for use (ifu).There were no damaged noted to the packaging of the device.The procedure was completed.The event did not cause a clinically relevant increase in the duration of the procedure.The event did not cause a condition that requires hospitalization or significant prolongation of existing hospitalization.Other additional procedural details were requested but were unknown.One product was returned for analysis.A non-sterile powerflex pro 6mm x 10cm x 80 was received coiled inside of a clear plastic bag.Per visual inspection the balloon was received without being inflated.No damages or anomalies were observed on the balloon or on the rest of the device.Functional analysis was performed.The guidewire lumen was flushed with water prior to the evaluation.A syringe was attached (filled with water) to the guidewire port.Positive pressure was applied, and water flowed through the entire lumen and exited the distal tip as expected, no resistance to water flow nor foreign material was observed during the flushing procedure.A lab sample guidewire of the appropriate size was inserted to the wire lumen trough the wire port to determine if resistance/friction or obstruction can be observed.The guide wire traveled completely inside the lumen and came out by the distal tip successfully.The inflator/deflator device was attached to the hub.Balloon inflation was performed by applying pressure with the inflator/deflator.The balloon was inflated as expected.Pressure was increased until the manometer reached the rated burst pressure of 15 atm, at this condition the balloon continued to inflate, and no leakage was observed.The balloon inflation test was performed successfully.X-ray analysis was performed.The product was evaluated using an x ray machine to determine if the metal of the marker¿s bands have a radiopacity characteristic.The obtained image confirms the marker bands radiopacity.A product history record (phr) review of lot 82155904 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿marker band balloon catheters - inadequate radiopacity¿ was not confirmed by analysis of the returned device.Functional analysis was performed successfully, and the device performed as intended.An x-ray analysis was then performed, the radiopacity test on the x ray machine was performed successfully and confirmed the marker band¿s radiopacity.It is likely that procedural factors contributed to the event reported.Based on the information provided, it is difficult to draw a clinical conclusion between the device and the event reported.According to the instructions for use, which is not intended as a mitigation of risk, ¿two radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement.The radiopaque marker bands indicate the stated nominal length of the balloon.Note: perform all further catheter manipulations under fluoroscopy.¿ 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 6MM10CM 80
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 9401228
• Report Number: 9616099-2019-03379
• Device Sequence Number: 11304411
• Product Code: LIT
• UDI-Device Identifier: 20705032059579
• UDI-Public: 20705032059579
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2020

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: 05/31/2021
• Device Model Number: 4400610S
• Device Catalogue Number: 4400610S
• Device Lot Number: 82155904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 12/09/2019; 03/03/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 01/03/2020; 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1