MAUDE Adverse Event Report: COOK INC ONE-PART PERCUTANEOUS ENTRY NEEDLE; DRC TROCAR

Catalog Number SDN-21-7.0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/18/2022

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) number: exempt.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 via a medwatch report, during a cardiac catheterization in which a cook one-part percutaneous entry needle was used, another manufacturer's wire guide unraveled and separated in the patient.Access was obtained in the femoral artery, using the cook needle.The anatomy was not scarred, tortuous, or calcified.After blood return was verified, the other manufacturer's 0.021-inch nitinol wire guide was inserted into the needle.Resistance was reported upon wire advancement, shortly after exiting the needle.The user retracted the wire to reorient it; however, the wire would not come back.The user then attempted to remove the wire and needle.The needle was completely removed; however, the wire unraveled and remained in the patient.Contralateral arterial access was obtained, and it was determined that the wire was not in the arterial system and therefore could not be snared.The user then tried to remove the wire from the access site, but the wire unraveled and separated in the patient, leaving approximately one inch of the other manufacturer's wire in the soft tissue of the right groin.A section of the cook device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Event description: as reported via a medwatch report, during a cardiac catheterization in which a cook one-part percutaneous entry needle was used, another manufacturer's wire guide unraveled and separated in the patient.Access was obtained in the femoral artery, using the cook needle.The anatomy was not scarred, tortuous, or calcified.After blood return was verified, the other manufacturer's 0.021-inch nitinol wire guide was inserted into the needle.Resistance was reported upon wire advancement, shortly after exiting the needle.The user retracted the wire to reorient it; however, the wire would not come back.The user then attempted to remove the wire and needle.The needle was completely removed; however, the wire unraveled and remained in the patient.Contralateral arterial access was obtained, and it was determined that the wire was not in the arterial system and therefore could not be snared.The user then tried to remove the wire from the access site, but the wire unraveled and separated in the patient, leaving approximately one inch of the other manufacturer's wire in the soft tissue of the right groin.A section of the cook device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation - evaluation.Reviews of specifications and quality control data were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There were no identified gaps in the quality control procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The customer did not provide the lot number for the complaint device.Cook reviewed the sales history for this customer and was unable to identify the complaint lot.Reviews of the device history record and complaint history record could not be completed due to lack of lot information from the user facility.From the information provided upon review of the customer testimony and device master record (dmr), cook concluded that the device was manufactured to specification and no nonconforming devices exists in house or out in the field.As reported by the customer, another manufacturer's nitinol wire was used.Per the wire guide manufacturer's website, the instructions for use (ifu) for the wire guide cautions the user not to withdraw the guidewire back into a metal needle cannula, as shearing of the wire may result.Cook has concluded that there is no evidence that a cook device malfunctioned.The quality engineering risk assessment was not reviewed as there is no evidence that a cook device malfunctioned.We will continue to monitor for similar complaints.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: ONE-PART PERCUTANEOUS ENTRY NEEDLE
• Type of Device: DRC TROCAR
• 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: 14000662
• MDR Text Key: 290159913
• Report Number: 1820334-2022-00527
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SDN-21-7.0
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: TERUMO PINNACLE PRECISION ACCESS SYSTEM'S WIRE
• Patient Outcome(s): Other