MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 6MM22CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4400622S

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot (82179728) presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a non-cordis guidewire cannot advanced into the lumen of a 6mm x 22cm x 80cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter till the end.It was completely blocked and was not able to advance.The non-cordis guidewire experienced heavy friction in the catheter lumen approximately at four-fifths (4/5) of the length of the balloon.There was no reported patient injury.The device was stored and handled per the instructions for use (ifu).There were no visible signs of device/package damage prior to use.The device was prepped according to instructions for use (ifu).The device was prep normally.The difficulty was encountered while loading the balloon over the guide wire.There were no visible kinks/bends noted on either one of the devices.The cannula wire port or guidewire lumen was not obstructed.The insertion difficulty was possibly caused by a blockage of injectable material.The difficulty requires that only the reported product was removed.There was excessive torque used during advancement or delivery of the device.When the first resistance was perceived, the surgeon persisted.An extra +- 5cm was achieved, before blocking completely.There were no kink/bent noted after device was removed from patient.The device will be returned for analysis.

Manufacturer Narrative

As reported, a non-cordis guidewire cannot be advanced into the lumen of a 6mm x 22cm x 80cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter till the end.It was completely blocked and was not able to advance.The non-cordis guidewire experienced heavy friction in the catheter lumen approximately at four-fifths (4/5) of the length of the balloon.There was no reported patient injury.The device was stored and handled per the instructions for use (ifu).There were no visible signs of device/package damage prior to use.The device was prepped according to instructions for use (ifu).The device was prep normally.The difficulty was encountered while loading the balloon over the guide wire.There were no visible kinks/bends noted on either one of the devices.The cannula wire port or guidewire lumen was not obstructed.The insertion difficulty was possibly caused by a blockage of injectable material.The difficulty requires that only the reported product was removed.There was excessive torque used during advancement or delivery of the device.When the first resistance was perceived, the surgeon persisted.An extra +- 5cm was achieved, before blocking completely.There were no kink/bent noted after device was removed from patient.The product was returned for analysis.One non-sterile unit of a powerflex pro 6mm x 22cm 80 along with an unknown hydrophilic guidewire was received for analysis coiled inside a plastic bag.Per visual analysis, no anomalies were observed on the received powerflex pro.Per functional analysis, a lab sample syringe filled with water was attached to the hub of the received catheter and successfully flushed.Neither obstruction nor loosen material/matter was observed during flushing procedure.Then, an emerald guide wire.035¿ lab sample was successfully passed through the inner lumen of the unit.Neither obstruction nor resistance felt/experienced during the functional test.Also, a guidewire insertion /withdrawal test was performed with the concomitant hydrophilic guidewire received.The hydrophilic guidewire was able to pass through the lumen of the unit.However, resistance was felt during insertion.Therefore, a thorough microscopical inspection was performed on the received hydrophilic guidewire.Per microscopic analysis, the hydrophilic guidewire was inspected under the vision system and it could be observed some anomalies on the coating of the concomitant guidewire.Some sort of peeling and abrasions were observed all along through the coating of the hydrophilic guidewire.Per dimensional analysis, the outer diameter (od) of the lab sample and concomitant guidewires were performed.No anomalies found.Also, a dimensional analysis was performed to verify the correct inner diameter (id) of the guidewire lumen of the unit at the proximal, middle a distal zone.The measurements were found within specification.A product history record (phr) review of lot 82179728 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿guidewire lumen- obstructed¿ was not confirmed as the device passed functional, insertion and withdrawal testing, as well as id measurements during device analysis.The exact cause of the reported event cannot be determined.It is likely handling of the device with the concomitant hydrophilic wire contributed to the reported events, as evidenced by the resistance noted during analysis.Per microscopic analysis, the hydrophilic guidewire was observed to have some anomalies on the coating of the guidewire.Some sort of peeling and abrasions were observed all along through the coating of the hydrophilic guidewire.According to the safety information in the instructions for use ¿prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Flush the ¿thru¿ lumen with sterile heparinized saline or a similar isotonic solution.Place the prepared catheter over a prepositioned guidewire and advance the tip to the introduction site.If resistance is met during manipulation, determine the cause of the resistance before proceeding.Consider the use of systemic heparinization.Flush all devices entering the vascular system with sterile heparinized saline or similar isotonic solution.If strong resistance is met during advancement or withdrawal of the catheter, discontinue movement and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the entire system.¿ neither the product history record (phr) review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process.Therefore, no corrective or preventive action will be taken at this time.

Manufacturer Narrative

After further review of additional information received the following sections g4, g7, h2 and h6 have been updated according.As reported, a non-cordis guidewire cannot advanced into the lumen of a 6mm x 22cm x 80cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter till the end.It was completely blocked and was not able to advance.The non-cordis guidewire experienced heavy friction in the catheter lumen approximately at four-fifths (4/5) of the length of the balloon.There was no reported patient injury.The device was stored and handled per the instructions for use (ifu).There were no visible signs of device/package damage prior to use.The device was prepped according to instructions for use (ifu).The device was prep normally.The difficulty was encountered while loading the balloon over the guide wire.There were no visible kinks/bends noted on either one of the devices.The cannula wire port or guidewire lumen was not obstructed.The insertion difficulty was possibly caused by a blockage of injectable material.The difficulty requires that only the reported product was removed.There was excessive torque used during advancement or delivery of the device.When the first resistance was perceived, the surgeon persisted.An extra +- 5cm was achieved, before blocking completely.There were no kink/bent noted after device was removed from patient.The product was not returned for analysis.A product history record (phr) review of lot 82179728 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿guidewire lumen- obstructed¿ was not confirmed as the device was not returned for analysis.The exact cause of the reported event cannot be determined.It is likely handling of the device and procedural factors may have contributed to the event reported.However, without the return of the device for analysis, it is difficult to draw a clinical conclusion between the device and the events reported.According to the safety information in the instructions for use ¿prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Flush the ¿thru¿ lumen with sterile heparinized saline or a similar isotonic solution.Place the prepared catheter over a prepositioned guidewire and advance the tip to the introduction site.If resistance is met during manipulation, determine the cause of the resistance before proceeding.Consider the use of systemic heparinization.Flush all devices entering the vascular system with sterile heparinized saline or similar isotonic solution.If strong resistance is met during advancement or withdrawal of the catheter, discontinue movement and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the entire system.¿ neither the phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process.Therefore, no corrective or preventive action will be taken at this time.Corrected data: section d10: device available for evaluation.

• Brand Name: POWERFLEXPRO 6MM22CM 80
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10378818
• MDR Text Key: 202020657
• Report Number: 9616099-2020-03833
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032059630
• UDI-Public: 20705032059630
• Combination Product (y/n): N
• PMA/PMN Number: K112797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 4400622S
• Device Catalogue Number: 4400622S
• Device Lot Number: 82179728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Initial Date Manufacturer Received: 07/23/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 09/01/2020; 09/14/2020
• Supplement Dates FDA Received: 09/02/2020; 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TERUMO GLIDE WIRE; TERUMO GLIDE WIRE