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

Catalog Number HNR4.0-35-70-ST-10S-PIG

Device Problem Material Separation (1562)

Patient Problem Surgical procedure, additional (2564)

Event Date 06/12/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, an angiography of the lower limb of a patient with aso (arteriosclerosis obliterans) was performed by right cfa (common femoral artery) approach.The complaint device was advanced into the target site through a guiding sheath inserted from right cfa.After angiography was finished, the physician inserted a wire guide into the catheter so as to retrieve it.However, the wire guide perforated the wall of the catheter.Retrieval of the catheter was continued though, but separation of the tip of the catheter and the remaining of the separated segment in the body was confirmed.It is unknown if the catheter separated "when being retrieved" or "when the wire guide was being inserted into it".The separated segment was retrieved successfully by using another manufacturer's snare (the site of approach or technique used when retrieving the segment were unknown).

Manufacturer Narrative

(b)(4).A review of the complaint history, device history record, instructions for use (ifu), quality control (qc) and a visual inspection of the complaint device was conducted for the purpose of this investigation.The product was returned in an opened and used condition.Visual exam of the returned device found the catheter tip to be brittle displaying an approximate 8mm longitudinal split beginning at the distal opening running proximal.There was a circumferential separation of a 5-6 mm segment of the nytts material.There is no evidence to suggest that the product was not manufactured to specifications.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 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, manager ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4919530
• MDR Text Key: 21770627
• Report Number: 1820334-2015-00389
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/12/2015

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: 08/01/2016
• Device Catalogue Number: HNR4.0-35-70-ST-10S-PIG
• Device Lot Number: 4462226
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/23/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/12/2015
• Device Age: 30 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/15/2015
• Initial Date FDA Received: 07/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• 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