MAUDE Adverse Event Report: CORDIS CORPORATION 6F .070 XB 3 100CM; CATHETER, PERCUTANEOUS

Model Number N/A

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/12/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17967466 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, there was a reddish clot like substance in the lumen of a 6f.070 100cm vista brite tip extra back-up (xb) guiding catheter.The procedure was completed using another unknown guide catheter.There was no reported patient injury.The device was opened in sterile field.The procedure was a percutaneous transluminal coronary angioplasty (ptca) with stent placement of the proximal circumflex (lcx) and mid left anterior descending artery (lad) using a right femoral approach.The lcx had 90% stenosis and the lad had 90% stenosis.Other procedural details were requested but are unknown, unavailable, or not applicable.The device will be returned for evaluation.Photographs were provided and available for review.

Manufacturer Narrative

Complaint conclusion: as reported, there was a reddish clot like substance in the lumen of a 6f.070 100cm vista brite tip extra back-up (xb) guiding catheter.The procedure was completed using another unknown guide catheter.There was no reported patient injury.The device was opened in sterile field.The procedure was a percutaneous transluminal coronary angioplasty (ptca) with stent placement of the proximal circumflex (lcx) and mid left anterior descending artery (lad) using a right femoral approach.The lcx had 90% stenosis and the lad had 90% stenosis.Other procedural details were requested but are unknown, unavailable, or not applicable.Initially, 2 photographs were provided for review.The first picture shows the outer label, and the following information can be read: catalogue# 67005200, lot# 17967466, and use by date 2023-07-31.As part of the second picture, it can be observed the hub of the catheter, and a red spot can be noticed inside de hub, however the image is not clear.No other anomalies on the product can be noticed at the attached pictures.At a later date, a non-sterile unit of a vista brite tip catheter (6f.070 xb 3 100cm) was received for analysis.During the visual inspection no anomalies were detected on the body of the catheter.In addition, no red spot could be noticed.Per microscopic analysis, the unit was inspected under the vision system to see if the spot was present however it could not be found.A product history record (phr) review of lot 17967466 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 ¿catheter (body/shaft)-foreign material¿ was not confirmed since the red spot could not be found at the hub neither on the rest of the catheter.The cause of the failure reported could not be conclusively determined during analysis.Procedural or patient 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 product analysis suggests that the reported failure could be related to the manufacturing process of the unit.No corrective or preventive actions will be taken.

• Brand Name: 6F .070 XB 3 100CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11617948
• MDR Text Key: 243931872
• Report Number: 9616099-2021-04388
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 20705032020142
• UDI-Public: 20705032020142
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 67005200
• Device Lot Number: 17967466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Date Manufacturer Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BMW GUIDEWIRE; UNKNOWN GUIDE CATHETER; YUKON CHOICE 2.75X12MM PC ELITE DES STENT; YUKON CHOICE 3.0X18MM PC ELITE DES STENT; BMW GUIDEWIRE; UNKNOWN GUIDE CATHETER; YUKON CHOICE 2.75X12MM PC ELITE DES STENT; YUKON CHOICE 3.0X18MM PC ELITE DES STENT
• Patient Age: 73 YR