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

Model Number N/A

Device Problem Split (2537)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The pigtail of the catheter cracked along the length of the black part during injection.The procedure was stopped and the device was changed.According to the initial reporter, there were no consequences to the patient.Additional information has been requested, but not provided by the reporter at the time of this report.

Manufacturer Narrative

(b)(4).Investigation - evaluation a review of complaint history, device record history, instructions for use (ifu), quality control, specifications and visual inspection of the returned device was conducted during the investigation.Two devices were returned in an opened and used condition.Visual inspection confirms material failure.One device had circumferential separation 8 mm distal of the bond joint, complete circumferential separation 1.5 mm distal of the bond joint and longitudinal splits running the length of the separated tip.The other device has 3 longitudinal splits beginning 1.0 cm distal the bond joint and extending to the tip.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: "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." a capa request was initiated as part of the recall actions to further investigate the incident.The device is part of recall z-2317/2319-2015 / res: 71692 z-0798-2016 / res72387.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.

Event Description

The pigtail of the catheter cracked along the length of the black part during injection.The procedure was stopped and the device was changed.According to the initial reporter, there were no consequences to the patient.Additional information has been requested, but not provided by the reporter at the time of this report.

• 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: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 5207146
• MDR Text Key: 30584469
• Report Number: 1820334-2015-00722
• 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: foreign,other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/14/2015

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 Model Number: N/A
• Device Catalogue Number: HNR4.0-35-100-P-10S-PIG
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/20/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/01/2015
• Device Age: 34 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/14/2015
• Initial Date FDA Received: 11/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2317/2319-2015
• Patient Sequence Number: 1