MAUDE Adverse Event Report: COOK INC BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number HNBR5.0-35-100-P-NS-SIM1

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Occupation = other healthcare professional: ir tech.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during an unknown procedure, the hub of a beacon tip torcon nb advantage angiographic catheter separated from the device.Access was obtained in the radial artery using an amplatz extra stiff wire guide.Reportedly, the tip of the device became "disconfigured" as it entered the internal carotid.As the user twisted the device, the hub separated.Another manufacturer's catheter was used to complete the procedure.The patient's outcome is reported as good.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Initial report: as reported, during an unknown procedure, the hub of a beacon tip torcon nb advantage angiographic catheter separated from the device.Access was obtained in the radial artery using an amplatz extra stiff wire guide.Reportedly, the tip of the device became "disconfigured" as it entered the internal carotid.As the user twisted the device, the hub separated.Another manufacturer's catheter was used to complete the procedure.The patient's outcome is reported as good.Investigation - evaluation: reviews of the drawing, documentation, instructions for use (ifu), manufacturer¿s instructions, and quality control procedures were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document-based investigation evaluation was performed.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.A review of the quality control procedures and manufacturing instructions was conducted, and no gaps were discovered.Thus, there is evidence to support that the device was manufactured to specification.An ifu is provided with this device which states, ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ the ifu further notes as a precaution, ¿if resistance is encountered during manipulation, stop and determine the cause before proceeding any further.¿ based on the available information, investigation has concluded that, while the reason for the failure could not be determined, possible reasons for the occurrence could be complications related to patient anatomy, handling of the device, and/or the nature of the procedure.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9844782
• MDR Text Key: 194481938
• Report Number: 1820334-2020-00633
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K173289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/22/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: HNBR5.0-35-100-P-NS-SIM1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 03/17/2020
• Supplement Dates Manufacturer Received: 04/13/2020
• Supplement Dates FDA Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1