MAUDE Adverse Event Report: CORDIS CORPORATION SI BRITE TIP 8F 55CM STR; INTRODUCER, CATHETER

Model Number	401855M
Medical Device Problem Codes	Difficult to Insert (1316); Torn Material (3024)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the brite tip sheath introducer tip was frayed.The sheath was replaced with a new brite tip sheath and the procedure was completed successfully.There was no reported patient injury.This was a percutaneous transluminal angioplasty (pta) case.A brite tip sheath was attempted to be inserted into a vessel but resistance was felt.The device was removed and the distal tip was confirmed to be frayed.The target lesion was unknown.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.No damages were noted to the sheath.The device was flushed prior to insertion.The product stored, handled, inspected and prepped according to the instructions for use (ifu).There was nothing unusual noted about the device prior to use. the product was not returned for analysis.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.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the reported issue.Without the return of the devices for analysis, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made.According to the product instructions for use, users are cautioned to inspect the guiding catheter before use to verify that its size, shape and condition are suitable for the specific procedure.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Therefore, no corrective or preventative actions will be taken at this time.
Event or Problem Description
It was reported that the brite tip sheath introducer tip was frayed.The sheath was replaced with a new brite tip sheath and the procedure was completed successfully.There was no reported patient injury.This was a percutaneous transluminal angioplasty (pta) case.A brite tip sheath was attempted to insert into a vessel but there was resistance felt.The device was removed and the distal tip was confirmed to be frayed.The target lesion was unknown.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.No damages were noted to the sheath.The device was flushed prior to insertion.The product stored, handled, inspected and prepped according to the instructions for use (ifu).There was nothing unusual noted about the device prior to use.The product was clinically used and will not be returned for analysis.

• Brand Name: SI BRITE TIP 8F 55CM STR
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 6569185
• Report Number: 9616099-2017-01098
• Device Sequence Number: 10989222
• Product Code: DYB
• UDI-Device Identifier: 20705032000410
• UDI-Public: 20705032000410
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K984500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2017

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: 12/31/2018
• Device Model Number: 401855M
• Device Catalogue Number: 401855M
• Device Lot Number: 17414181
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2017
• Initial Report FDA Received Date: 05/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1