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

Catalog Number	HNBR5.0-35-65-P-NS-VANSCHIE4
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Investigation- a review of the complaint history, device history record, instructions for use (ifu), quality control (qc), specifications, and a visual inspection of the complaint device was conducted for the purpose of this investigation.The catheter was returned.However the tip was not returned with the catheter.A recall expansion was initiated for the beacon tip catheters on 07oct2015.However, this product is not within the scope of the recall.Prior to shipment the manufacturer, confirms the tip material meets the requirements for tensile strength and elongated.Quality control performs the following in-process and requires the following inspections: ¿perform a pull test using the instron tensile tester on each order received.¿ / "verify surface of catheter is free of damage and excess bumps or roughness.Wire braided catheter surface must also be free of exposed wires¿ / "verify distal tip/endhole is rounded smooth, not thin, slanted or out of round.No splits, nicks, damage, excess material or debris present." 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." measures have previously been taken to address this issue.The appropriate internal personnel will be notified and we will continue to monitor for similar complaints.
Event or Problem Description
A hybrid tevar bypass lcca (left common carotid artery)-lsca (left subclavian artery) procedure was performed on a (b)(6) male patient with pre-existing condition of taa (thoracic aortic aneurysm).Information was provided that the patient came with a taa but with not enough proximal landing zone.The doctor decided to do hybrid procedure.After embolization procedure at (b)(6), the doctor removed the vanschie4 catheter from the body of the patient body and noted the tip was missing.Fluoroscopy revealed the tip was located above the coil.The doctor attempted to snare the fragmented tip, but was unsuccessful.Therefore, he decided to tie lsca above the tip, hoping that it will thrombose later.Additional information was requested.However is was not provided at the time of this report.
Additional Manufacturer Narrative
This report is being submitted retrospectively per fda request.All information for this event was previously submitted from (b)(6)2016-(b)(6)2016.
Additional Manufacturer Narrative
F.10) patient code: foreign body in patient is not labeled.Device code: tip separation is not labeled.Additional investigation evaluation information: the visual inspection of the returned device reported the device was returned for investigation without the beacon tip.Visual inspection confirmed circumferential separation of the beacon tip 2 mm distal of the bond.Additionally, there are no signs of tip elongation.Visual inspection of the device confirms material degradation of the beacon tip.This product is shipped with an ifu which in addition to the information below 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." investigation evaluation as previously reported in the initial medwatch report: a review of the complaint history, device history record, instructions for use (ifu), quality control (qc), specifications, and a visual inspection of the complaint device was conducted for the purpose of this investigation.The catheter was returned.However the tip was not returned with the catheter.Prior to shipment the manufacturer, confirms the tip material meets the requirements for tensile strength and elongated.Quality control performs the following in-process and requires the following inspections: ¿perform a pull test using the instron tensile tester on each order received.¿ / "verify surface of catheter is free of damage and excess bumps or roughness.Wire braided catheter surface must also be free of exposed wires¿ / "verify distal tip/endhole is rounded smooth, not thin, slanted or out of round.No splits, nicks, damage, excess material or debris present." 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." measures have previously been taken to address this issue.The appropriate internal personnel will be notified and we will continue to monitor for similar complaints.
Event or Problem Description
A hybrid tevar bypass lcca (left common carotid artery)-lsca (left subclavian artery) procedure was performed on a 71 year old male patient with pre-existing condition of taa (thoracic aortic aneurysm).Information was provided that the patient came with a taa but with not enough proximal landing zone.The doctor decided to do hybrid procedure.After embolization procedure at orific of lsca, the doctor removed the vanschie4 catheter from the body of the patient body and noted the tip was missing.Fluoroscopy revealed the tip was located above the coil.The doctor attempted to snare the fragmented tip, but was unsuccessful.Therefore, he decided to tie lsca above the tip, hoping that it will thrombose later.Additional information was requested.However is was not provided at the time of this report.

• Brand Name: TORCON NB ADVANTAGE VAN SCHIE BEACON TIP SEEKING CATHETER
• Common Device Name: 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: 5526122
• Report Number: 1820334-2016-00169
• Device Sequence Number: 498771
• Product Code: DQO
• UDI-Device Identifier: 00827002137837
• UDI-Public: (01)00827002137837(17)160801(10)4476421
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2016

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
• Operator of Device: Health Professional
• Device Catalogue Number: HNBR5.0-35-65-P-NS-VANSCHIE4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/02/2016
• Device Age: 31 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2016
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1820334-14APR2016-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male