MAUDE Adverse Event Report: CATH ST 5F SIM 1 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17955919 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 Description

When the surgeon took out the 5f 100cm straight (st) sidewinder simmons technique (sim1) super torque angiographic catheter from the patient, the tip disengaged from the catheter.There was no reported patient injury.The device will be returned for analysis.

Manufacturer Narrative

Complaint conclusion: when the surgeon took out the 5f 100cm straight (st) sidewinder simmons technique (sim1) super torque angiographic catheter from the patient, the tip disengaged from the catheter.There was no reported patient injury.Additional procedural details were requested but not provided.The device was not returned for analysis.A product history record (phr) review of lot 17955919 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Based on the information provided, it is not possible to draw a clinical conclusion between the device and the reported event.Without the return of the device for analysis, the reported customer event ¿brite tip/distal tip - catheters- separated¿ could not be confirmed and the exact root cause could not be determined.Procedural/handling factors or vessel characteristics (although not provided) could possibly contribute to this type of event.Per the instructions for use (ifu), which is not intended as a mitigation of risk, ¿exercise care when removing guidewires from multiple-curve catheters.To prevent kinking of 5f (1.65 mm) and smaller angiographic catheters; straighten the pigtail catheter tip only with a diagnostic guidewire or, if applicable, with a tip straightener.Do not straighten by hand.Use a guidewire when introducing the catheter through the catheter sheath introducer (csi) and into the left ventricle.Treat all 4f catheters and smaller french sizes with ultimate care.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.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 phr review nor the information available suggests that the event could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: CATH ST 5F SIM 1 100CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 10861451
• MDR Text Key: 216933696
• Report Number: 9616099-2020-04069
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032011648
• UDI-Public: 10705032011648
• Combination Product (y/n): N
• PMA/PMN Number: K915836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 532501
• Device Lot Number: 17955919
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1