MAUDE Adverse Event Report: CORDIS CORPORATION CATH F5 INF AR II MOD 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 534543T

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot (17133302) 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, two 5f infiniti catheters were expired by the time they were used in surgery.This was noticed after the procedure was done when the patient file was being prepared.The physician noticed that the label was modified, specifically in the expiration date.When the coas was reviewed, the product was noted to have been expired 2 years before (2017) and the date quoted was (b)(6) 2019.There was n reported patient injury.The target lesion was the right coronary artery (rca).After the product was used and implanted in the patient it was realized that the product had an expired date.There was not outer box.There were only two (2) catheters.There was no illegible printing of the date, but it was inconsistent regarding font and size.The product inventory is managed at cath lab, first in first out (fifo).The facility places it easier to hand in their inventories.The cath lab team collects the label from every used device.A non-very common curve or size (catheter type), may be considered a neglect or hectic schedule.The devices will not be returned for analysis.

Manufacturer Narrative

After further review of additional information received the following sections g4, g7, if follow-up, what type, device evaluated by mfr have been updated accordingly.Two 5f infiniti catheters were expired by the time they were used in surgery.This was noticed after the procedure was done when the patient file was being prepared.The physician noticed that the label was modified, specifically in the expiration date.When the coas was reviewed, the product was noted to have been expired 2 years before ((b)(6)) and the date quoted was 2019-09.There was no reported patient injury.The target lesion was the right coronary artery (rca).After the product was used and implanted in the patient it was realized that the product had an expired date.There was no outer box.There were only two catheters.There was no illegible printing of the date, but it was inconsistent regarding font and size.The product inventory is managed at cath lab, first in first out (fifo).The facility places it easier to hand in their inventories.The cath lab team collects the label from every used device.A non-very common curve or size (catheter type), may be considered a neglect or hectic schedule.A file with one picture of an inner label from a reported cath f5 inf ar ii mod 100cm diagnostic catheter was received attached to the (b)(4).Neither the involved unit in the procedure nor the mentioned label were returned for analysis.Per visual analysis of the attached picture, a product label with the following listed main information was observed: part: 534-543t, lot: 17133302; expiration date: (b)(6) 2019.The expiration date verification was performed and it was concluded that the expiration date was within the specified use by date (ubd) requirements at time of sale.Per additional analysis, the image of the label reported by the complaint was analyzed and the following was observed: the image of the label taken from the router and the image of the label reported by the complaints are the same except for the ubd with date of 2019-09.There are two places were the ubd is shown/printed in the label.The first one is the section mentioned with the discrepancy.The second one is embedded in the secondary bar code.The secondary barcode is composed by three parts; the ubd, lot number, and a verification number.Both bar codes are the same which match in both labels.Additionally, the labels show the same footprint which indicates that it is from the original printed labels and not a reprint.A product history record (phr) review of lot 17133302 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 ¿packaging/pouch/box - expiration date exceeded¿ were not confirmed since an expiration date verification was performed and it was concluded that the expiration date was within the specified ubd requirements at time of sale.However, it was confirmed that the devices were used beyond the expiration date during the procedure.The complaints ¿packaging/pouch/box - labeling incorrect¿ and ¿packaging/ pouch/box - improper distribution - suspected tampering" were confirmed due to the ubd quoted on the label was observed as (b)(6) 2019 and the correct ubd date was confirmed to be (b)(6) 2017 during the analyses.It was observed that the image of the label taken from the router and the image of the label reported by the customer are the same, except for the ubd with date of 2019-09.A discrepancy was noted in one of the sections where the ubd is printed.In addition, once the label is generated only one ubd is taken to print the label and generate the barcode.Also, the label reported is not a reprint since the footprint is the same.Based on the review of the images provided and manufacturing records, it was determined that the product labels had been tampered with (expiration date changed).However, a root cause for the observed events could not be conclusively determined solely based on the picture reviews.According to the instructions for use (ifu), which is not intended as a mitigation, ¿do not use if package is open or damaged.Do not use the catheter if the ¿use by¿ date on the package label has expired.Do not resterilize.¿ per the disclaimer of warranty and limitation of remedy on the ifu, ¿there is no express or implied warranty, including without limitation any implied warranty of merchantability or fitness for a particular purpose, on the cordis product(s) described in this publication.Under no circumstances shall cordis be liable for any direct, incidental, or consequential damages other than as expressly provided by specific law.No person has the authority to bind cordis to any representation or warranty except as specifically set forth herin.Descriptions or specifications in cordis printed matter, including this publication, are meant solely to generally describe the product at the time of manufacture and do not constitute any express warranties.Cordis corporation will not be responsible for any direct, incidental, or consequential damages resulting from reuse of the product.¿ neither the phr review nor the picture analyses suggest that the reported complaints are related to the manufacturing process of the units.However, a corrective action has been opened to further address this issue.This is one of 2 products involved with the reported event and the associated manufacturer report numbers are 9616099-2019-03235.

Manufacturer Narrative

The device will not be returned for evaluation.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

This device is available for analysis but the engineering report is not yet available.  however, it will be submitted within 30 days upon receipt.

• Brand Name: CATH F5 INF AR II MOD 100CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 9130803
• MDR Text Key: 160567618
• Report Number: 9616099-2019-03236
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032013830
• UDI-Public: 20705032013830
• Combination Product (y/n): N
• PMA/PMN Number: K970854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 534543T
• Device Lot Number: 17133302
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1