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

Model Number	67012600
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 17725671 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 or Problem Description
As reported, the connected part of the 6f x.070¿ x 100cm extra back-up (xb) right coronary artery (rca) vista brite tip guiding catheter (gc) had a leaked during prep.There was no reported patient injury.The device was stored as per the labeling.The device was not resterilized and was prepped following instructions for use (ifu).There were leakage anomalies noted when the device was taken out of the package and when pulled from the packaging by the hub.Other additional procedural details were requested but are unknown.The device is expected to be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections g4, g7, h2, h3and h6 have been updated accordingly.As reported, the connected part of the 6f vista brite tip guiding catheter (gc) had a leak during prep.There was no reported patient injury.The device was stored as per the labeling.The device was not resterilized and was prepped following instructions for use (ifu).There were leakage anomalies noted when the device was taken out of the package and when pulled from the packaging by the hub.Other additional procedural details were requested but are unknown.The device was not returned for evaluation.A product history record (phr) review of lot 17725671 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Based on the information provided, it is not possible to draw a clinical conclusion between the device and the reported event.Without the return of the device for analysis, the reported customer event ¿luer hub ¿ catheters - leakage - during prep¿ could not be confirmed and the exact root cause could not be determined.Handling factors might have contributed to this issue.According to the ifu, which is not intended as a mitigation, ¿store in a cool, dark, dry place.Do not use open or damaged packages.Use prior to the ¿use by¿ date.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.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.Prior to use, flush the guiding catheter lumen with a heparinized saline solution.¿ neither the phr review nor the information available suggests that the event reported by the customer could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: 6F .070 XB RCA 100CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 9607919
• Report Number: 9616099-2020-03490
• Device Sequence Number: 10909110
• Product Code: DQY
• UDI-Device Identifier: 20705032020654
• UDI-Public: 20705032020654
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K021593
• 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
• Report Date (Section B): 02/11/2020

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: 09/30/2020
• Device Model Number: 67012600
• Device Catalogue Number: 67012600
• Device Lot Number: 17725671
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 01/20/2020
• Supplement Report FDA Received Date: 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 75