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

Catalog Number HNR4.0-35-65-P-8S-VCF

Device Problem Material Separation (1562)

Patient Problem Foreign body, removal of (2365)

Event Date 10/15/2014

Event Type  Injury  

Event Description

Physician used a catheter to run a first angiogram of the lower aorta and bifurcation from right femoral artery entry.From a contra-lateral approach he used the same catheter to transfer his wire to the left common iliac.He advanced the vcf over the wire down to the left external iliac to run a second angiogram.He decided that the patient will need surgery and tried to pull his catheter out of this very calcified left external iliac; however, the distal black tip tore off at the distal joint and stayed in the patient over the wire.The wire was holding the radiopaque tip from moving down the leg.The physician had to replace the 6fr short introducer for a larger 8fr short introducer to be able to leave the wire in and have enough space to introduce a snare to successfully retrieve the radiopaque distal tip.The physician used another manufacturer 8fr angioseal as a final step.Except for the fact that the patient had to have a longer procedure, the patient was fine and returned home at the end of the day with no adverse effect noted.

Manufacturer Narrative

(b)(4).Event is still under investigation.

• 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: 4254627
• MDR Text Key: 5106838
• Report Number: 1820334-2014-00591
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 10/15/2014

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: 06/01/2017
• Device Catalogue Number: HNR4.0-35-65-P-8S-VCF
• Device Lot Number: 5018947
• Other Device ID Number: UDI#: (01)00827002123946(17)17
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/04/2014
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/15/2014
• Device Age: 4 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/23/2014
• Initial Date FDA Received: 11/05/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2014
• 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