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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems Foreign body, removal of (2365); No Code Available (3191)

Event Date 05/14/2015

Event Type  Injury  

Event Description

Embolization of the aneurysm in the internal iliac artery of a male patient with a preexisting history of an aneurysm and history of y-graft implantation.(the complaint device was used for angiography before the embolization procedure).The complaint device was advanced to the target area through a sheath (detail: unknown).However, something like a burr on the catheter was observed on the monitor of the fluoroscope, the catheter was retrieved out of the body so that the physician could check what the burr like object was.This was confirmed to be the separation of the tip of the catheter.Afterwards, it was confirmed under fluoroscopic control that the separated segment remained in the artery near the tip of the sheath.The separated segment could be retrieved out of the body by using snare, but a small piece likely flaked from the separated segment (though it was unknown what this piece was) still remained in the branch of the iliac artery.However, the physician determined there would be no problems due to this piece and remained as it was.The procedure was continued by using another device and the iia embolization itself was completed successfully.No adverse effects to the patient were reported.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Manufacturer Narrative

(b)(4).Event evaluation: a functional test along with a review of the complaint history, device history record, instructions for use (ifu), quality control and a visual inspection of the two returned products (one, unused and one, used) was conducted during the investigation.Functional testing of the returned, unused, sealed device using a.035 wire guide split the tip circumferentially beginning 1cm distal of the bond joint.Once split, the tip then split an additional 4mm longitudinally around the top of the pigtail.Functional testing of the returned, used device noted a circumferential separation beginning approximately 1.3cm distal of the bond joint; the break of the proximal portion then split into 3 separate longitudinal sections [resembling a tripod].The separated tip was returned in 3 pieces ¿ the largest being a 3.2cm strip of what most likely was the top of the pigtail.The remaining 2/3 of the curve is missing.The material exhibited brittle characteristics.The images provided from the physician show a small piece of the catheter tip that separated and remained in the patients body.The returned wire guide and sheath were undamaged.This product is shipped with an instructions for use (ifu); 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." action has been previously initiated in order to investigate this failure mode.The device is involved in recall no.Z-2317/2319-2015.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.

Event Description

Embolization of the aneurysm in the internal iliac artery of a male patient with a preexisting history of an aneurysm and history of y-graft implantation.(the complaint device was used for angiography before the embolization procedure).The complaint device was advanced to the target area through a sheath (detail:unknown).However, something like a burr on the catheter was observed on the monitor of the fluoroscope.The catheter was retrieved out of the body so that the physician could check what the burr-like object was; which was confirmed to be separation of the tip of the catheter.Afterwards, it was confirmed under fluoroscopic control that the separated segment remained in the artery near the tip of the sheath.The separated segment could be retrieved out of the body by using snare, but a small piece likely flaked from the separated segment (though it was unknown what this piece was) still remained in the branch of the iliac artery.However, the physician determined there would be no problems due to this piece and remained as it was.The procedure was continued by using another device and the iia embolization itself was completed successfully.No adverse effects to the patient were reported.

• Brand Name: BEACON TIP ROYAL FLUSH PLUS FLUSH CATHETER
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4845045
• MDR Text Key: 5868503
• Report Number: 1820334-2015-00365
• 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,distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2016
• Device Model Number: N/A
• Device Catalogue Number: HNR4.0-35-70-P-10S-PIG
• Device Lot Number: F4500351
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/14/2015
• Device Age: 20 MO
• Event Location: Hospital
• Date Manufacturer Received: 05/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• 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): Required Intervention