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

Model Number G09469

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 11/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).Occupation: non-healthcare professional (initial reporter).Pma/510(k) number: k173289.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during placement of a cook gastrostomy tube, the tip of a beacon tip torcon nb advantage angiographic catheter separated in the patient¿s left nostril.The male patient reportedly had a history of cancer of the neck, affecting the oropharynx.The complaint device was used for diagnostic placement of the gastrostomy tube, using imaging.The patient was reportedly conscious; however, ¿some drugs¿ were used.The user inserted the complaint device into the nostril, pulled back ¿a little bit¿, and realized that the entire tip was lodged in the soft tissue and separated.It is unknown if any lubricant was used; however, per the physician, it is possible that lidocaine was used for patient comfort.The physician reported minimal resistance and buckling of the catheter upon insertion of the device.An unknown angled, non-stiff glidewire was in the lumen of the device at the time of insertion.The anatomy was reported to be normal.The device is reportedly stored in the lab closet/hospital suite that is sterilized with a ¿standard bleach wipe-down method¿.The procedure was completed using another catheter through the right nostril for diagnostic placement of the g-tube.An ear, nose, and throat surgeon attempted to remove the tip of the device at the bedside, but this was not tolerated by the patient.Three follow-up procedures were conducted to determine the location of the separated portion of the device, including nasal endoscopy, ct scan, and abdominal x-ray.An attempted retrieval was conducted in the operating room under general anesthesia; however, the tip could not be located.An abdominal x-ray reportedly confirmed that the tip was in the patient¿s colon.Per the physician, the patient¿s final outcome is unknown; however, the patient ¿likely suffered no permanent harm from this; but it is too early to tell¿.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.H6 method code- trend analysis (4110), communication/interviews (4111).Summary of event: as reported, during placement of a cook gastrostomy tube, the tip of a beacon tip torcon nb advantage angiographic catheter separated in the patient¿s left nostril.The male patient reportedly had a history of cancer of the neck, affecting the oropharynx.The complaint device was used for diagnostic placement of the gastrostomy tube, using imaging.The patient was reportedly conscious; however, ¿some drugs¿ were used.The user inserted the complaint device into the nostril, pulled back ¿a little bit¿, and realized that the entire tip was lodged in the soft tissue and separated.It is unknown if any lubricant was used; however, per the physician, it is possible that lidocaine was used for patient comfort.The physician reported minimal resistance and buckling of the catheter upon insertion of the device.An unknown angled, non-stiff glidewire was in the lumen of the device at the time of insertion.The anatomy was reported to be normal.The device is reportedly stored in the lab closet/hospital suite that is sterilized with a ¿standard bleach wipe-down method¿.The procedure was completed using another catheter through the right nostril for diagnostic placement of the g-tube.An ear, nose, and throat surgeon attempted to remove the tip of the device at the bedside, but this was not tolerated by the patient.Three follow-up procedures were conducted to determine the location of the separated portion of the device, including nasal endoscopy, ct scan, and abdominal x-ray.An attempted retrieval was conducted in the operating room under general anesthesia; however, the tip could not be located.An abdominal x-ray reportedly confirmed that the tip was in the patient¿s colon.Per the physician, the patient¿s final outcome is unknown; however, the patient ¿likely suffered no permanent harm from this; but it is too early to tell¿.Investigation evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control procedures, specifications, and trends was conducted during the investigation, as well as a visual inspection and dimensional verification of the complaint device and of unused product.Inspection of the complaint device confirmed that one hnbr5.0-38-65-p-ns-kmp was returned without the tip.Other than this separation, no additional damage was noted to the device.The device measured 64.85 centimeters from the end to proximal fitting.A document-based investigation evaluation was also performed.No failure-related non-conformances were found for the product lot, and there have been no other reported complaints for this lot number.The complaint file, device history record, complaint history, and manufacturing documents provide evidence that the device was manufactured to specification.Additional devices from the complaint lot which were retained by cook were also inspected.All tested devices exceeded the in-process requirement for separation at the bond site per industry standards.There is no evidence of nonconforming devices from the complaint lot in house or in the field.Reviews of the drawing and manufacturing and quality control instructions revealed no evidence to suggest a gap in the manufacturing process.The product ifu states, ¿manipulation of the catheter requires fluoroscopic control.If resistance is encountered during manipulation, stop and determine the cause before proceeding any further.Do not attempt to heat or reshape the catheter curve; the catheter tip is made from a heat-sensitive material.¿ instructions for use include, ¿flush the device prior to use.Under fluoroscopic guidance, advance the catheter over an appropriately sized wire guide or through an appropriately sized sheath introducer to the intended location.Note: if resistance is encountered during manipulation, stop and determine the cause before proceeding any further.¿ in addition, as a precaution, retraining was completed for manufacturing and quality control employees related to the bonding process.Based on the information provided and the results of the investigation, cook has concluded that a definitive cause for this event cannot be established.This occurrence is being reviewed to determine the need for further investigation of the failure mode.The appropriate personnel have been notified and cook will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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
• MDR Report Key: 9323079
• MDR Text Key: 166397317
• Report Number: 1820334-2019-02881
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00827002094697
• UDI-Public: (01)00827002094697(17)210806(10)9910687
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/29/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2021
• Device Model Number: G09469
• Device Catalogue Number: HNBR5.0-38-65-P-NS-KMP
• Device Lot Number: 9910687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 11/14/2019
• Supplement Dates Manufacturer Received: 05/07/2020
• Supplement Dates FDA Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR