MAUDE Adverse Event Report: COOK, INC. BEACON TIP ROYAL FLUSH PLUS FLUSH CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number HNR4.0-35-100-P-10S-PIG

Device Problem Device, or device fragments remain in patient (1527)

Patient Problem Nonresorbable materials, unretrieved in body (2276)

Event Date 03/26/2015

Event Type  Injury  

Event Description

A (b)(6) male weighing (b)(6) experienced endovascular aortic repair on (b)(6) 2015.The complaint product was used for angiography during the procedure.The physician mistakenly inserted the pig-tail straightener into a sheath simultaneously with the catheter without knowing it.An angiography was performed that confirmed the pig-tail straightener was in the artery.Retrieval of the device was judged to be difficult.The physician decided to continue the procedure and sealed the pig-tail straightener was in the artery.Retrieval of the device was judged to be difficult.The physician decided to continue the procedure and sealed the pig-tail straightener in the space between a stent graft and the vessel wall of the right common iliac artery.The physician provided the following comment: "the cause of this event is technical error.As i did not follow ifu instruction, this event occurred.If the pig-tail straightener has been manipulated just as labeled/standard way of procedure, there would have been no possibility of pig-tail straightener remaining in the patient's body." no adverse effects to the patient were reported.

Manufacturer Narrative

(b)(4).A review of complaint history and the instructions for use (ifu) was conducted during the investigation.The physician provided the following comment: "the cause of this event is technical error; as i did not follow ifu instruction, this event occurred.If the pig-tail straightener had been manipulated just as labeled/standard way of procedure, there would have been no possibility of pig-tail straightener's remaining in the patient's body." this product is shipped with an ifu which states under instructions for use: "peel-away straightener must not be used as a vascular introducer sheath." there was no defect with the product.The user not following the instructions for use led to this failure mode.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.

• Brand Name: BEACON TIP ROYAL FLUSH PLUS FLUSH CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: larry pool, mgr. ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4795874
• MDR Text Key: 5858445
• Report Number: 1820334-2015-00320
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HNR4.0-35-100-P-10S-PIG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/26/2015
• Event Location: Hospital
• Date Manufacturer Received: 04/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Disability
• Patient Age: 75 YR
• Patient Weight: 67