MAUDE Adverse Event Report: CORDIS CORPORATION 6F .070 XB 3 100CM; CATHETER, PERCUTANEOUS

Model Number	67005200
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.This device was received for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Event or Problem Description
During prep, it was reported that the distal of the adroit guiding catheter was ruptured (separated) after it was removed from the packaging.There was no patient injury.Another adroit guiding catheter was used to compete the procedure.The device was handled according to the instruction for use (ifu).There were no difficulties removing the product from the packaging.There were no damages to the device packaging.There were no excessive force used before the procedure.
Additional Manufacturer Narrative
During device prep for an unknown procedure, it was reported that the distal tip of the adroit guiding catheter was ruptured (separated) after it was removed from the packaging.There was no patient injury reported.Another adroit guiding catheter was used to compete the procedure.The device was handled according to the instruction for use (ifu).There were no difficulties removing the product from the packaging.There were no damages to the device packaging.There was no excessive force used before the procedure.No other information was reported.The device was returned for analysis.One non-sterile unit of a 6f.070 xb 3 100cm guiding catheter was received for analysis inside a plastic bag.No original packaging box or pouch bag was returned.Per visual analysis, the device was kinked at 14.2 cm, at 46.0 cm, at 48.2 cm, at 79.8 cm and at 97.4 cm from inner diameter (id) band.The outer diameter (od) and id of the device were measured near to the kinked areas and the results were found within specification.No other anomalies were noted.A product history record (phr) review of lot 17791025 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 ¿brite tip/distal tip ¿ catheters-separated - during prep¿ was not confirmed.However, several kinked conditions were found on the body shaft of the device as received.Nonetheless, the root cause of the kinks on the body shaft of the device could not be conclusively determined during the analysis.Storage and handling factors may have contributed to the kinked conditions identified during the analysis.Per the precautions in the instructions for use (ifu), which is not intended as a mitigation, ¿store in a cool, dark, dry place.Do not use if package is open or damaged.Do not use the catheter if the ¿use by¿ date on the package label has expired.Do not resterilize.Exposure to temperatures above 54c (130f) may damage the catheter.To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.¿ neither the phr review nor the product analysis suggest that the reported events are related to the manufacturing process.Therefore, no corrective or preventative actions will be taken at this time.

• Brand Name: 6F .070 XB 3 100CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes 00000
• MDR Report Key: 8196284
• Report Number: 9616099-2018-02599
• Device Sequence Number: 16725794
• Product Code: DQY
• UDI-Device Identifier: 20705032020142
• UDI-Public: 20705032020142
• 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: foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2019

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: 05/31/2021
• Device Model Number: 67005200
• Device Catalogue Number: 67005200
• Device Lot Number: 17791025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1