MAUDE Adverse Event Report: CORDIS CORPORATION 6F .070 JL4 100CM; CATHETER, PERCUTANEOUS

Model Number 67000400

Device Problems Peeled/Delaminated (1454); Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.Visual analysis: no product was received for analysis, instead three pictures were attached at the complaint file.At the first picture the following conditions are observed: the catheter is a non-sterile product, the packaging pouch is already open.A kinked/bent condition is present on the catheter body.The catheter is placed on the mounting card.The device is partially packaging inside the outer box.The outer box label show that is a jl 4, 6f product, catalogue number 670-004-00, and the lot number is 17887323.The other two pictures show the catheter placed on the mounting card and out of the outer box, but in different angle.The kinked/bent condition is marked with a circle on one of the pictures.The unit and the mounting card are blood saturated.No other details of the product can be noticed at the attached pictures.It is unknown if the device will be returned for testing and evaluation.   additional information is pending and will be submitted within 30 days upon receipt.

Event Description

During operation, the 6f vista bite tip guiding catheter.070 judkins left (jl) 4 x 100cm was found damaged.There was no reported patient injury.The damage was noted during removal from the packaging.Additional procedural details were requested but were unknown.The device will be returned for evaluation.Per clinician image review, two images were received for analysis.Image 1 is a picture of a 6f vista brite tip guiding catheter box and inner package next to it.The device is visible inside the inner package.The device appears to have been used as there are blood residues near the proximal end of the catheter and on the hub.Although the image has poor clarity, the catheter body/shaft has a notable anomaly on the outer surface.The material appears to have a sharp cut, exposing the braidwire/corewire.The material around the cut anomaly appears stretched.Image 2 appears to be a less magnified version of image 1.The box of a 6f vista brite tip guiding catheter is pictured with the inner package next to it.The device is visible inside the inner package.The image has poor clarity and the details of the noted anomaly are not clearly visible.

Manufacturer Narrative

Complaint conclusion: the 6f vista bite tip guiding catheter was found damaged.There was no reported patient injury.The damage was noted during removal from the packaging.Additional procedural details were requested but were unknown.No product was received for analysis, instead three pictures were attached at the complaint file.For the first picture the following conditions were observed: the catheter is a non-sterile product, the packaging pouch is already open.A kinked/bent and a puncture/cut condition are present on the catheter body.The catheter is placed on the mounting card.The device is partially packaged inside the outer box.The outer box label shows that is a jl 4, 6f product, catalogue number 670-004-00, and the lot number is 17887323.The other two pictures show the catheter placed on the mounting card and out of the outer box, but in a different angle.The kinked/bent and puncture/cut conditions are marked with a circle on one of the pictures.The unit and the mounting card are blood saturated.No other details of the product can be noticed from the attached pictures.A product history record (phr) review of lot 17887323 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaint reported by the customer as ¿catheter (body/shaft) - exposed braidwire/corewire during prep¿ and ¿catheter (body/shaft) - puncture/cut during prep¿ was confirmed, as a perforation on the body of the catheter is visible.Also, a kinked/bent condition was observed on the catheter body.The exact root cause of these damages could not be conclusively determined solely on the analysis of the received pictures.Storage/handling factors may have contributed to the reported event.According to the instructions for use (ifu), which is not intended as a mitigation of risk, ¿store in a cool, dark, dry place.Do not use open or damaged packages.Do not resterilize.Do not expose to organic solvents.Inspect the guiding catheter before use to verify that its size, shape, and condition are suitable for the specific procedure.¿ the recommended procedure section in the ifu states, ¿remove the guiding catheter from its packaging.Inspect the guiding catheter upon removal from packaging to verify that it is undamaged.Warning: do not use a guiding catheter that has been damaged in any way.If damage is detected, replace with an undamaged guiding catheter.¿ neither the phr review nor the picture analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

Manufacturer Narrative

Complaint conclusion: the 6f vista bite tip guiding catheter was found damaged.There was no reported patient injury.The damage was noted during removal from the packaging.Additional procedural details were requested but were unknown.Three pictures and were attached at the complaint file and the product was received for analysis.For the first picture the following conditions were observed: the catheter is a non-sterile product, the packaging pouch is already open.A kinked/bent and a puncture/cut condition are present on the catheter body.The catheter is placed on the mounting card.The device is partially packaged inside the outer box.The outer box label shows this is a jl 4, 6f product, catalogue number 670-004-00, and the lot number is 17887323.The other two pictures show the catheter placed on the mounting card and out of the outer box, but in a different angle.The kinked/bent and puncture/cut conditions are marked with a circle on one of the pictures.The unit and the mounting card are blood saturated.No other details of the product can be noticed from the attached pictures.A non-sterile unit of a vista brite tip guiding catheter (6f.070 jl4 100cm) was received coiled inside of a clear plastic bag.During the visual inspection, a twist/kink/bent condition on the body of the catheter was observed located at 88 cm from the distal tip.In addition, other kinked areas were noted all along the catheter at 27, 38.5, 51 and 53 cm from the distal tip.No other damages or anomalies were observed on the returned device.Dimensional analysis was performed to verify the correct catheter inner diameter (id) and outer diameter (od).Measurements were taken near the damages and dimensional analysis results were found within specification.A product history record (phr) review of lot 17887323 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaints reported by the customer as ¿catheter (body/shaft)- exposed braidwire/corewire - during prep¿ and ¿catheter (body/shaft-puncture/cut - during prep¿ was confirmed since during the visual analysis, several kinks were located at the catheter body, including a twist/ kink/bent condition in where braidwire could be seen.The exact cause of these damages noticed on the device could not be conclusively determined during the analysis.Dimensional analysis results were found within specification.Storage/handling factors might have contributed to this issue.According to the instructions for use (ifu), which is not intended as a mitigation of risk, ¿store in a cool, dark, dry place.Do not use open or damaged packages.Do not resterilize.Do not expose to organic solvents.Inspect the guiding catheter before use to verify that its size, shape, and condition are suitable for the specific procedure.¿ the recommended procedure section in the ifu states, ¿remove the guiding catheter from its packaging.Inspect the guiding catheter upon removal from packaging to verify that it is undamaged.Warning: do not use a guiding catheter that has been damaged in any way.If damage is detected, replace with an undamaged guiding catheter.¿ neither the phr review nor the product or picture analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: 6F .070 JL4 100CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10022078
• MDR Text Key: 200032082
• Report Number: 9616099-2020-03685
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 20705032019887
• UDI-Public: 20705032019887
• Combination Product (y/n): N
• PMA/PMN Number: K021593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2020

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: 07/31/2022
• Device Model Number: 67000400
• Device Catalogue Number: 67000400
• Device Lot Number: 17887323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Initial Date Manufacturer Received: 04/08/2020
• Initial Date FDA Received: 05/04/2020
• Supplement Dates Manufacturer Received: 05/28/2020; 07/01/2020
• Supplement Dates FDA Received: 06/10/2020; 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1