MAUDE Adverse Event Report: CORDIS DE MEXICO CATH F5 INF PIG145 110CM 6SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	534552S
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis.  device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
It was reported that the f5 infiniti catheter pig 145 110cm 6sh hub twisted off the catheter while the device was torqued.Everything was removed safely from the body.There were no patient injury.
Additional Manufacturer Narrative
It was reported that the f5 infiniti catheter pig 145 110 cm 6sh hub twisted off the catheter while the device was torqued.Everything was removed safely from the body (the device was pulled through the sheath).Another pigtail infiniti catheter was used to complete the procedure.There were no patient injury.The device was prepped according to the instruction for use (ifu) with no defect or difficulty noted.There was no defects noted to the packaging.The intended procedure was diagnostic lv gram.No other additional information was received.The device was not returned for analysis.Two pictures were received.Per visual analysis of the received pictures, it was observed that the hub was separated from the catheter and elongations were observed at the body separated from hub area.No other issues were observed.A device history record (dhr) review of lot 17459439 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿luer hub - separated - during use¿ was confirmed by the pictures received.Since the product was not received for analysis, the cause of the separation could not be conclusively determined.However, based on the information available for reviewed, procedural/handling factors may have contributed to separation reported as evidenced by the presence of elongation noted in the pictures.Manipulation of the catheter under excessive friction due to interaction with other devices or while trapped in the vasculature, can lead to stretching or elongation of the catheter.Furthermore, if resistance is felt during manipulation, a physician is trained to determine the cause of resistance before proceeding and confirm the catheter positioning under high quality fluoroscopic observation.Neither the dhr review results nor the separation observed on the pictures suggest that the reported events may be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: CATH F5 INF PIG145 110CM 6SH
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• MDR Report Key: 6454777
• Report Number: 9616099-2017-01017
• Device Sequence Number: 693549
• Product Code: DQO
• UDI-Device Identifier: 20705032013922
• UDI-Public: 20705032013922
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K970854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2017

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: 03/31/2019
• Device Model Number: 534552S
• Device Catalogue Number: 534552S
• Device Lot Number: 17459439
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/09/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2017
• Supplement Report FDA Received Date: 05/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1