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

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

Device Problem Tip breakage (1638)

Patient Problem Nonresorbable materials, unretrieved in body (2276)

Event Date 05/26/2014

Event Type  Injury  

Event Description

A (b)(6) male patient experienced evar against aaa on (b)(6) 2014.A delivery system of a stentgraft (detail: unk) was advanced below renal artery from right cfa and then, so as to perform angiography before stentgraft deployment, the complaint catheter was advanced below renal artery over a wire guide from left cfa.After the wire guide was retrieved, angiography was conducted through the catheter and the catheter was withdrawn out of the body.Then, the stentgraft was deployed in the lesion successfully.However, when the physician checked the lesion under fluoroscopic control after the deployment, it was noticed that the tip of the catheter had separated and was caught in the space between the stentgraft and the wall of the aorta.Although the separated segment still remains in the body, no adverse effects to the patient have been observed by now.

Manufacturer Narrative

(b)(4).Product was returned in an opened and used condition.A visual inspection noted that the distal tip had separated from the catheter shaft.The separation appeared to be a smooth break due to a brittle separation.A review of the complaint history, the ifu, inspection instructions and a visual inspection of the device were performed.A final inspection for angiographic catheters verifies surface of catheter is free of damage, excess bumps or roughness, and foreign matter.This product is shipped with an ifu which states under precautions: "due to thinwall 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." the patient event information stated: "when the physician checked the lesion under fluoroscopic control after the deployment, it was noticed that the tip of the catheter had separated and was caught in the space between the stentgraft and the wall of the aorta." it is possible that the device saw resistance beyond its design.The appropriate internal personnel have been notified and will continue to monitor for similar events.The risk assessment was used to access the risk and a capa has been initiated to help reduce/alleviate this failure mode.

• Brand Name: BEACON TIP ROYAL FLUSH PLUS FLUSH CATHETER
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 3902215
• MDR Text Key: 22001497
• Report Number: 1820334-2014-00255
• 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: 05/28/2014,05/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2016
• Device Catalogue Number: HNR4.0-35-100-P-10S-PIG
• Device Lot Number: 4461704
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/03/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/26/2014
• Device Age: 9 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/27/2014
• Initial Date FDA Received: 06/24/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/26/2013
• 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): Other
• Patient Age: 83 YR
• Patient Weight: 38