MAUDE Adverse Event Report: CORDIS CORPORATION 6F .070 JR 4 LBT 100CM; CATHETER, PERCUTANEOUS

Model Number	6700820L
Medical Device Problem Codes	Material Frayed (1262); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/30/2020
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, the 6f vista brite tip guiding catheter was attempted to be used for a procedure, however, it was confirmed that the distal end was frayed before insertion.So, it was not used for the procedure and was replaced with a new unknown guiding catheter to complete the procedure.There was no reported patient injury.This was a percutaneous coronary intervention (pci) case.The device will not be returned for evaluation because it was discarded due to suspicious infectious disease.
Additional Manufacturer Narrative
Complaint conclusion: as reported, the 6f vista brite tip guiding catheter was attempted to be used for a procedure, however, it was confirmed that the distal end was frayed before insertion.It was not used for the procedure and was replaced with a new unknown guiding catheter to complete the procedure.There was no reported patient injury.This was a percutaneous coronary intervention (pci) case.Additional procedural details were requested but not provided.The device was not returned for evaluation because it was discarded due to suspicious infectious disease.A product history record (phr) review of lot 17879504 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 ¿brite tip/distal tip ¿ catheters - frayed/split/torn - during prep¿ could not be confirmed and the exact root cause could not be determined.Storage/handling factors may have contributed to the reported event.Per 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.¿ ¿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 information available suggests that the event 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 JR 4 LBT 100CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 9995903
• Report Number: 9616099-2020-03668
• Device Sequence Number: 3836797
• Product Code: DQY
• UDI-Device Identifier: 20705032020456
• UDI-Public: 20705032020456
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/08/2020

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: 06/30/2022
• Device Model Number: 6700820L
• Device Catalogue Number: 6700820L
• Device Lot Number: 17879504
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/30/2020
• Supplement Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 04/24/2020
• Supplement Report FDA Received Date: 05/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK GUIDING CATHETER.; UNK GUIDING CATHETER