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

Model Number	534552S
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	05/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 17907029 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
When retracting the 5f 110cm 145 infinity pigtail with 6 sideholes (sh) diagnostic catheter out of patient through femoral approached, it was noted the tip was absent.The catheter tip was still inside patient.Therefore, vascular surgeon was called to retrieve the end of catheter using a gooseneck snare.There was no harm to the patient.As per sales rep ¿retrieval of catheter tip was successfully achieved.Patient outcome fine.¿ the device was opened in the sterile field.It was a routine cardiac procedure using infinity pigtail diagnostic catheter.The infinity user was trained.As per sales rep ¿it was noted from the original packaging that it had not been opened completely.The catheter was taken out of packaging without opening the plastic completely and removing from the cardboard¿.The device will be returned for analysis.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b5, d10, g4, g7, h1, h2, h3 and h6.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, when retracting the 5f 110cm 145 infinity pigtail with 6 sideholes (sh) diagnostic catheter out of patient through femoral approached, it was noted the tip was absent.The catheter tip was still inside patient.Therefore, the vascular surgeon was called to retrieve the end of catheter using a gooseneck snare.There was no harm to the patient.As per the sales rep ¿retrieval of catheter tip was successfully achieved.Patient outcome fine.¿ it was a routine cardiac procedure using infinity pigtail diagnostic catheter.The infinity user was trained.The device was opened in the sterile field.The device was not re-sterilized.There were no anomalies noted when the device was removed from the package or during prep.As per sales rep ¿it was noted from the original packaging that it had not been opened completely.The catheter was taken out of packaging without opening the plastic completely and removing from the cardboard¿ and "it could have been kinked at that junction point were it snapped off because it was pulled out of the packaging without opening the clear package completely".The device was not inserted through a stopcock instead of a hemostatic valve.Additional procedural details were requested but are unknown.The device will be returned for analysis.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g4, g7, h1, h2, h3 and h6.When retracting the 5f 110cm 145 infinity pigtail with 6 sideholes (sh) diagnostic catheter out of patient through femoral approach, it was noted the tip was absent.The catheter tip was still inside patient.Therefore, the vascular surgeon was called to retrieve the end of catheter using a gooseneck snare.There was no harm to the patient.As per the sales rep ¿retrieval of catheter tip was successfully achieved.Patient outcome fine.¿ it was a routine cardiac procedure using infinity pigtail diagnostic catheter.The infinity user was trained.The device was opened in the sterile field.The device was not re-sterilized.There were no anomalies noted when the device was removed from the package or during prep.As per sales rep ¿it was noted from the original packaging that it had not been opened completely.The catheter was taken out of packaging without opening the plastic completely and removing from the cardboard¿ and "it could have been kinked at that junction point were it snapped off because it was pulled out of the packaging without opening the clear package completely".The device was not inserted through a stopcock instead of a hemostatic valve.Additional procedural details were requested but are unknown.Images have been attached for review.One non-sterile unit of a pigtail infinity catheter (cath f5 inf pig145 110cm 6sh) was received for analysis.During the visual inspection, the brite tip was found separated, both parts were returned for evaluation.No other damages or anomalies were observed.Results showed the separated area of the body/shaft of the infinity catheter presented evidence of elongations and a flared condition on the body/shaft material.No other anomalies were observed.The elongations and the flared condition found on the body/shaft material are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the body/shaft material was induced to a tensile force that exceeded the body/shaft material yield strength prior to the separation.No other anomalies were observed during sem analysis.A product history record (phr) review of lot 17907029 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported event by the customer as ¿brite tip/distal tip ¿ separated - in-patient¿ was confirmed since the device was received separated.The elongations and the flared condition found on the body/shaft material are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the body/shaft material was induced to a tensile force that exceeded the body/shaft material yield strength prior to the separation.Procedural and/or handling factors (removal of the device from the packaging) additionally might have contributed to the reported conditions.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿do not use if package is open or damaged.Exercise care when removing guidewires from multiple-curve catheters.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.Before use, flush all devices entering a blood vessel with sterile heparinized saline or a similar isotonic solution.Keep the catheter filled with either flushing solution or contrast medium while the catheter is in the vascular system and consider the use of systemic heparinization.Forcibly aspirate and flush the catheter with heparinized saline solution at least once every two minutes.Procedures requiring percutaneous catheter introduction should not be attempted by physicians unfamiliar with the possible complications.Complications may occur at any time during or after the procedure.¿ neither the product analysis nor the phr review results suggest that this damage is related to the manufacturing process of the unit.Therefore, no corrective or preventative actions will be taken.

• Brand Name: CATH F5 INF PIG145 110CM 6SH
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10130106
• Report Number: 9616099-2020-03726
• Device Sequence Number: 1848254
• Product Code: DQO
• UDI-Device Identifier: 20705032013922
• UDI-Public: 20705032013922
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K970854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 534552S
• Device Catalogue Number: 534552S
• Device Lot Number: 17907029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 05/21/2020; 07/14/2020
• Initial Report FDA Received Date: 06/08/2020
• Supplement Report FDA Received Date: 06/17/2020; 07/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1