MAUDE Adverse Event Report: COOK INC ROYAL FLUSH PLUS FLUSH CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number G04894

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/08/2023

Event Type  Injury  

Event Description

As reported, during an endovascular aneurysm repair (evar) procedure, a royal flush plus flush catheter's peel-away straightener was left in the patient.After advancement over an unspecified 0.035-inch wire guide, the catheter's peel away straightener was pulled back but was not removed from the catheter.Resistance was not encountered with manipulation or advancement of the catheter during the procedure, during which six-to-nine-french sheaths were used.Per the physician, the peel-away straightener was left on the catheter and used "again and again" for reinsertion of the same catheter during the "complex, long" procedure.Reportedly, the post-operative course was uneventful; however, the patient was readmitted through the emergency department six days after the evar procedure with groin and lower abdominal pain.A computed tomography angiography (cta) scan revealed a foreign body in the left femoral artery.The peel-away straightener was then removed from the patient during a surgical procedure.Per the physician, it is believed that the peel-away straightener "slipped in" through the arterial sheath during the evar procedure and remained within the artery after the catheter was removed.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Initial reporter name and address= (b)(6).Initial reporter occupation = distributor.Pma/510(k) number =pre-amendment.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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.

Manufacturer Narrative

Summary of event: as reported, during an endovascular aneurysm repair (evar) procedure, a royal flush plus flush catheter's peel-away straightener was left in the patient.After advancement over an unspecified 0.035-inch wire guide, the catheter's peel away straightener was pulled back but was not removed from the catheter.Resistance was not encountered with manipulation or advancement of the catheter during the procedure, during which six-to-nine-french sheaths were used.Per the physician, the peel-away straightener was left on the catheter and used "again and again" for reinsertion of the same catheter during the "complex, long" procedure.Reportedly, the post-operative course was uneventful; however, the patient was readmitted through the emergency department six days after the evar procedure with groin and lower abdominal pain.A computed tomography angiography (cta) scan revealed a foreign body in the left femoral artery.The peel-away straightener was then removed from the patient during a surgical procedure.Per the physician, it is believed that the peel-away straightener "slipped in" through the arterial sheath during the evar procedure and remained within the artery after the catheter was removed.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.A document-based investigation evaluation was performed.No lot-related non-conformances were found, and there have been no other reported complaints for this lot number.The product ifu states "after initial advancement of the catheter over the wire guide, pull back and peel away the straightener for catheter introduction" and ¿peel-away straightener must not be used as a vascular introducer sheath¿.The information provided upon review of the dmr, dhr, and ifu suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that failure to follow instructions contributed to this event.The ifu instructs the user to pull back and peel away the straightener for catheter introduction, and states that the pull away straightener must not be used as a vascular introducer sheath.The physician in this case reported that the peel-away straightener was left on the catheter and used "again and again" for reinsertion of the same catheter during the procedure.The risk analysis was reviewed and no additional escalation was required.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.

Event Description

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

• Brand Name: ROYAL FLUSH PLUS FLUSH CATHETER
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 16456970
• MDR Text Key: 310407253
• Report Number: 1820334-2023-00196
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00827002048942
• UDI-Public: (01)00827002048942(17)250930(10)14984971
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G04894
• Device Catalogue Number: HN5.0-38-100-P-10S-PIG
• Device Lot Number: 14984971
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2022
• 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
• Treatment: 0.035" AMPLATZ SUPER STIFF WIRE; 0.035" BENTSON WIRE; 0.035" LUNDERQUIST WIRE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male