MAUDE Adverse Event Report: COOK, INC. BEACON TIP AUROUS CENTIMETER VESSEL SIZING CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number NR5.0-35-100-P-10S-0-CS

Device Problem Material Separation (1562)

Patient Problem Foreign body, removal of (2365)

Event Date 05/18/2015

Event Type  Injury  

Event Description

As they were trying to manipulate the catheter to turn backwards, the catheter tip broke off.They had the tip snared but were having trouble pulling it out.The reporter confirmed the tip was removed from the pt's body.The device will not be returned as the facility is going to keep it for their own investigation.A section of the device did not remain inside the pt's body.According to the initial reporter, the pt did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).A review of the complaint history, instructions for use and qual control was conducted for the purpose of this investigation.No prod was returned to assist with the investigation.Qual control final inspection for angiographic catheters certifies the surface of the catheter is free of damage and excess bumps or roughness.Wire braided catheter surface also verified to be free of exposed wires.The distal tip/endhole is verified for roundness and smoothness, not thin, slanted, or out of round.Also, the device is verified for splits, nicks damage, excess material or dirias present.This prod is shipped with instructions for use which states under precautions: "due to thin wall construction, extreme care must be exercised during manipulation and withdrawal.Catheter insertion through a synthetic vascular graft should be avoided whenever possible."/"the possible whiplash effect of the long, soft catheter tip must be considered during selective angiography." we are inconclusive as to why this failure mode occurred.The appropriate cook inc personnel have been notified and we will continue to monitor for similar complaints.

• Brand Name: BEACON TIP AUROUS CENTIMETER VESSEL SIZING CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: larry pool, mfr ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4853549
• MDR Text Key: 5808687
• Report Number: 1820334-2015-00353
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2018
• Device Catalogue Number: NR5.0-35-100-P-10S-0-CS
• Device Lot Number: 5792943
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/18/2015
• Device Age: 1 MO
• Event Location: Hospital
• Date Manufacturer Received: 05/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2015
• 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
• Patient Outcome(s): Required Intervention