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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems Foreign body, removal of (2365); Surgical procedure, additional (2564); Device Embedded In Tissue or Plaque (3165)

Event Date 04/17/2015

Event Type  Injury  

Event Description

A female pt with left-foot dorsum melanoma conduced interventional therapy procedure on (b)(6) 2015.During introduction of the device into the pt, resistance was felt and the catheter bent.The tip of catheter then broke and fell into the right external iliac artery, while the catheter was being delivered to the right common iliac artery.The rest of the catheter was removed from the pt.Pt had an additional surgical procedure on (b)(6) 2015 to remove the tip of catheter.The procedure was completed and the tip was removed successfully.Four days later, the pt was in stable condition and was discharged from the hospital.

Manufacturer Narrative

(b)(4).No product was returned for eval.The customer did send images of the product; which indicated that one used device (detached circumferentially) and one unused and opened device (split circumferentially) had separated at the distal tip ~1mm from the bond site.A review of the complaint history, device history record, instructions for use (ifu), and quality control (qc) was conducted during investigation.Per quality control specification, it is stated: "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 instructions for use (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".As part of cook incorporated's quality system procedures, each complaint is investigated and as part of the investigation, risk is assessed, based on severity, detect-ability and occurrence.Based on this analysis, action taken may include the following: continued monitoring of similar events, corrective action or preventative action.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per quality engineering risk assessment, measures have previously been opened to address this failure mode.

Manufacturer Narrative

(b)(4).Event investigation - per information supplied by the customer, no product will be returned for evaluation.However, the customer did send images of the product which did indicate one used device (detached circumferentially) and one unused and opened device (split circumferentially), that the distal tip had separated approximately 1mm from the bond site.Quality control (qs) instructs personnel to verify that product is manufacture red according to specification.The patient event information stated: "during introduction of the device into the patient, resistance was felt and the catheter bent.The tip of catheter broke and fell into right external iliac artery, while being delivered the catheter to right common iliac artery.The rest of the catheter was removed from the patient." this product is shipped with an instruction for use( 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, "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." corrective actions have been enacted to investigate described failure modes.A complete review of complaint history, device history records, documentation, instructions for use (ifu), quality controls (qc), and specifications was conducted.Update (b)(6) 2016- affected products were not returned.However, images provided show circumferential separation of the used catheter tip approximately 2 mm distal of the bond joint.Images of an opened and unused catheter show circumferential splitting of the catheter tip approximately 2 mm distal of the bond joint.There are no signs of tip elongation for either catheter.These images are indicative of material degradation of the tip material.On (b)(6) 2015, a recall was initiated on any product manufactured with certain lot numbers.A recall expansion was initiated on (b)(6) 2015 for any product manufactured using additional raw material lot numbers.Another recall expansion was initiated on (b)(6) 2016 for any product manufactured with the beacon tip technology.This product is in scope of the recall.Prior to shipment to cook, incorporated, the approved supplier confirms the tip material meets the requirements for tensile strength and elongation noted in material specification.Cook, incorporated quality control performs in-process and final inspections to confirm product is made in accordance with quality control documents.This product was manufactured prior to quality control changes designed to correct potential defects.The appropriate (b)(6) personnel have been notified and we will continue to monitor for similar complaints.

Event Description

A female patient with left-foot dorsum melanoma conduced interventional therapy procedure on (b)(6) 2015.During introduction of the device into the patient, resistance was felt and the catheter bent.The tip of catheter then broke and fell into the right external iliac artery, while the catheter was being delivered to the right common iliac artery.The rest of the catheter was removed from the patient.Patient had an additional surgical procedure on (b)(6) 2015 to remove the tip of catheter.The procedure was completed and the tip was removed successfully.Four days later, the patient was in stable condition and was discharged from the hospital.

• Brand Name: BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC 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 47402 ; 8003462686
• MDR Report Key: 4925777
• MDR Text Key: 15594435
• Report Number: 1820334-2015-00398
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2015
• 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 Model Number: N/A
• Device Catalogue Number: HNBR5.0-38-80-P-NS-C2
• Device Lot Number: 4440259
• Other Device ID Number: (01)00827002085862
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/17/2015
• Device Age: 20 MO
• Event Location: Hospital
• Date Manufacturer Received: 06/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 60 YR