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 Component(s), broken (1103)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2015

Event Type  malfunction  

Event Description

After placing the catheter inside the aorta of a male pt, the catheter broke.

Manufacturer Narrative

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

Manufacturer Narrative

Per information supplied by the customer, no product will be returned.This product is shipped with an ifu 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." further efforts are being made in order to investigate this failure mode.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.

Event Description

While performing a catheterization, the catheter broke inside of the patient.Patient outcome was requested but not provided by the reporter.

• 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: larry pool, manager ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4589726
• MDR Text Key: 5340753
• Report Number: 1820334-2015-00148
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00827002112780
• UDI-Public: (01)00827002112780(17)160701(10)4363293
• Combination Product (y/n): N
• Reporter Country Code: PE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Unknown
• Type of Report: Initial,Followup
• Report Date: 02/06/2015

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 Expiration Date: 07/01/2016
• Device Catalogue Number: HNR4.0-35-100-P-10S-PIG
• Device Lot Number: 4363293

Other Device ID Number

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/06/2015
• Device Age: 20 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/13/2015
• Initial Date FDA Received: 03/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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