MAUDE Adverse Event Report: COOK INC TORCON NB ADVANTAGE VAN SCHIE BEACON TIP SEEKING CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem Surgical procedure, additional (2564)

Event Date 03/11/2015

Event Type  Injury  

Event Description

During an aortic stentgraft implantation on a male pt, the tip of the advantage van schie beacon tip catheter split into fragments.The fragments were retrieved from patient's body with a endovascular snare.According to the initial reporter, the pt did not experience or require any additional procedures due to this occurrence.

Manufacturer Narrative

(b)(6), (b)(4).A review of complaint history, instructions for use (ifu), and quality control was conducted during the investigation.Per info supplied by the customer, no product will be returned.Quality control verifies the surface of catheter is free of damage and excess bumps or roughness.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." we are inconclusive as to why this failure mode occurred.Quality engineering risk assessment was used to assess the risk of this complaint.The addition of this complaint does not change the conclusion that no further risk reduction is required.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.

Manufacturer Narrative

(b)(4).Investigation - evaluation: a review of complaint history, device history record, documentation, instructions for use (ifu), specifications and quality control was conducted during the investigation.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." "store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred." the complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.Capa investigation has previously been opened to investigate this failure mode, this product is in scope of the recall.This complaint will conservatively be accepted for capa.Through capa investigation it has been confirmed that this customer utilizes vaporized hydrogen peroxide (vhp) for total room decontamination.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.

Event Description

During a aortic stentgraft implantation on a male patient, the tip of the advantage van schie beacon tip catheter split into fragments.The fragments were retrieved from patient's body with a endovascular snare.According to the initial reporter, the patient did not experienced or required any additional procedures due to this occurrence.

• Brand Name: TORCON NB ADVANTAGE VAN SCHIE BEACON TIP SEEKING 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: 4778514
• MDR Text Key: 22039317
• Report Number: 1820334-2015-00268
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/13/2015

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: 08/18/2017
• Device Model Number: N/A
• Device Catalogue Number: HNBR5.0-35-65-P-NS-VANSCHIE2
• Device Lot Number: 5198211
• Other Device ID Number: (01) 00827002137943 (17) 17081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/13/2015
• Device Age: 8 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/14/2015
• Initial Date FDA Received: 05/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1820334-29JUN2015-002-R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention