MAUDE Adverse Event Report: CORDIS CORPORATION 6F .070 XB 3.5 100CM; CATHETER, PERCUTANEOUS

Model Number	67005400
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/07/2019
Type of Reportable Event	Malfunction
Additional 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.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, three vista brite tip guiding catheters (one - 6f.070 3 drc 100cm & two - 6f.070 xb 3.5 100cm) had holes in them.It was noted that the guides never entered the patient¿s body.There was no patient injury reported.The devices were not clinically used and will be returned for analysis.
Additional Manufacturer Narrative
As reported, three vista brite tip guiding catheters (one - 6f.070 3 drc 100cm & two - 6f.070 xb 3.5 100cm) had holes in them.It was noted that the guides never entered the patient¿s body.There was no patient injury reported.The devices were not clinically used.Multiple attempts to gather additional information and device return have been unsuccessful.The device was not returned for analysis.A product history record (phr) review of lot 17834969 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The phr review does not suggest that the event reported by the customer could be related to the manufacturing process.The reported ¿catheter (body/shaft) puncture/cut¿ events could not be confirmed as the devices were not received for analysis.The exact cause of the reported events cannot be determined.Storage and handling factors may have contributed to the events.Per the instructions for use (ifu), which is not intended as a mitigation, ¿warnings: discard the guiding catheter after one procedure.Structural integrity and/or function may be impaired through reuse or cleaning.Catheters are extremely difficult to clean after exposure to biological materials and may cause adverse patient reactions if reused.Do not use with ethiodol or lipiodol contrast media, or other such contrast media which incorporates the components of these agents.Precautions: 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.¿ the phr reviews do not suggest that the events experienced by the customer could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.Corrected data: section d10: device available for evaluation this is one of three products involved with the reported event and the associated manufacturer report numbers are 9616099-2019-02992, 9616099-2019-02993 and 9616099-2019-02994.

• Brand Name: 6F .070 XB 3.5 100CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 8675277
• Report Number: 9616099-2019-02992
• Device Sequence Number: 19365627
• Product Code: DQY
• UDI-Device Identifier: 20705032020166
• UDI-Public: 20705032020166
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K021593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2019

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: 12/31/2021
• Device Model Number: 67005400
• Device Catalogue Number: 67005400
• Device Lot Number: 17834969
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2019
• Supplement Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 107