MAUDE Adverse Event Report: CORDIS CORPORATION GC 7F 078 AL .75; CATHETER, PERCUTANEOUS

Model Number	77803400
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for analysis but the engineering report is not yet available.A review of the manufacturing documentation associated with lot 17694753 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 head-end of 7f.078".75 jal vista britetip guiding catheter was found fractured during use.Therefore, the device was replaced with another unknown guide catheter to complete the operation.It has no effect to the patient.There was no reported patient injury.The patient had history of coronary heart disease and had been implanted with unknown stent before.The patient had experienced pain causing his re-hospitalization.Following a radiographic examination, it was found that the left coronary artery (lca) has 80% stenosis that suggested a need to be re-treated with percutaneous coronary intervention (pci).The device was stored, handled and prepped per the instructions for use (ifu).There was no visible damage noted to the device prior to opening the package.The lesion was moderately calcified, with no vessel tortuosity.The device was not used for a chronic total occlusion (cto).The access site was the radial artery.There was no excess force used at any time during the procedure.The head-end was kinked.The device was removed in one piece.Another vista brite tip guiding catheter was used to complete the procedure.The device will be returned for evaluation.
Additional Manufacturer Narrative
Additional information was received and the product evaluation was completed and the catheter was observed to not be cracked but instead the brite/tip distal tip was kinked/bent.This file will no longer be reportable.

• Brand Name: GC 7F 078 AL .75
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10184335
• Report Number: 9616099-2020-03760
• Device Sequence Number: 2706634
• Product Code: DQY
• UDI-Device Identifier: 20705032021699
• UDI-Public: 20705032021699
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K972978
• 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): 07/15/2020

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: 06/30/2020
• Device Model Number: 77803400
• Device Catalogue Number: 77803400
• Device Lot Number: 17694753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 07/15/2020
• 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: UNKNOWN GUIDE CATHETER.
• Patient Age: 71 YR
• Patient Weight: 68