MAUDE Adverse Event Report: CORDIS COPORATION CATH MB 5F PIG 65CM 8SH; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2018

Event Type  Injury  

Manufacturer Narrative

It is not known if the device is available to be returned for analysis and no is selected in the report at this time.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

During withdrawal of a 5f 65cm supertorque plus pigtail diagnostic catheter from a tortuous and calcified iliac artery, there was ¿rupture of the probe at the level of the radiopaque markers and a piece of the probe remained in the patient.It was removed with a lasso.¿ the device will not be returned for analysis.

Manufacturer Narrative

During an unknown procedure, when withdrawing a 5f 65cm supertorque plus pigtail diagnostic catheter from a tortuous and calcified iliac artery, there was ¿rupture of the probe at the level of the radiopaque markers and a piece of the probe remained in the patient.It was removed with a lasso.¿ multiple attempts were made without success to obtain additional information.The device was not returned for analysis.A product history record (phr) review of lot 17694491 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 ¿catheter (body/shaft) separated - in-patient¿ could not be confirmed as the device was not returned for analysis and procedural films were not received.The exact cause could not be determined.Vessel characteristics, such as a high level of tortuosity and calcification, and procedural/handling factors may have contributed to the reported event.As per the instructions for use (ifu), which is not intended as a mitigation, ¿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.Do not advance or withdraw the supertorque® mb angiographic catheter within the vascular system unless it is preceded by a guidewire.Exercise care when removing guidewires from multiple-curve catheters.If resistance is felt during manipulation, determine the cause of resistance before proceeding and confirm supertorque® mb angiographic catheter positioning under high quality fluoroscopic observation.Do not exceed maximum pressure rating printed on label and hub.Avoid entrapment of the catheter between other endovascular devices and the vessel wall.Avoid excessive friction on the catheter; avoid simultaneous introduction of the catheter and aortic graft devices through the same sheath.Store in cool, dark, dry place.Do not use if the package is open or damaged.Exposure to temperatures above 54°c (130°f) may damage the catheter.¿ the phr review does not suggest that the events experienced by the customer could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.

Manufacturer Narrative

Correction to section (product code).

• Brand Name: CATH MB 5F PIG 65CM 8SH
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS COPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8070269
• MDR Text Key: 127120858
• Report Number: 9616099-2018-02525
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K915836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 532598C
• Device Lot Number: 17694491
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention