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 Problems Foreign body, removal of (2365); No Code Available (3191)

Event Date 12/04/2014

Event Type  Injury  

Event Description

The tip detached from the shaft of the catheter.The tip was retrieved with an endovascular snare.According to the initial reporter, the pt did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

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

Manufacturer Narrative

A review of complaint history, instructions for use (ifu), and quality control was conducted during the investigation.One device was returned in an opened and used condition, six other devices were returned unused.A visual inspection noted that the distal tip of the opened catheter had separated it appeared to be a brittle tip separation.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." there is no evidence to suggest that the product was not manufactured to specifications.We are inconclusive as to why this failure mode occurred.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), quality control, specifications and a visual inspection of the returned product were conducted during the investigation.Visual inspection of returned product showed circumferential separation of the used catheter tip approximately 1 mm distal of the bond joint.Additionally, there were no signs of tip elongation.Visual inspection of the device confirmed material degradation of the beacon tip.A capa request was initiated as part of the recall actions to further investigate the incident.This product is in scope of the 1820334-29jun2015-002-r recall.This product is shipped with an ifu which states under precautions: "due to thin wall 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." additionally it states, "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." we will continue to monitor for similar complaints and have notified the appropriate internal personnel.

Event Description

The tip detached from the shaft of the catheter.The tip was retrieved with an endovascular snare.According to the initial reporter, the patient did not experience any adverse effects 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 ; 8123392235
• MDR Report Key: 4416972
• MDR Text Key: 5418747
• Report Number: 1820334-2015-00030
• 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,Distributor,distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2015
• 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
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/06/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/04/2014
• Device Age: 4 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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