MAUDE Adverse Event Report: COOK INC RADIAL ARTERY PRESSURE MONITORING SET; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

Device Problems Complete Blockage (1094); Unable to Obtain Readings (1516)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/19/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter customer (person): phone: (b)(6).Initial reporter occupation: pharmaceutical.Pma/510(k) #: preamendment.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that the catheter of a radial artery pressure monitoring set did not "reflow" less than 12 hours after implantation, "without its exteriorization.".It is currently presumed that the device was occluded.The device was used for wrist blood pressure monitoring.It was also reported that the "tip of the catheter opens to the slip and find some resistance in the skin, making its introduction impossible".Clarification regarding this statement, as well as additional information regarding the patient, device, and event, has been requested.The patient did not experience any adverse effects.

Manufacturer Narrative

Correction: b1, b2, h1, h6 - annex f.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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

It was reported in additional information received on 06oct2021 that there was resistance when advancing the catheter over the wire.It was noted that there was bending between the catheter and the "fixation butterfly", causing obstruction "with very high frequency", despite the use of proper insertion and fixation techniques."slip" (as initially reported) referred to the tip of the catheter opening when sliding through the guide and encountering resistance in the skin.Seldinger technique was used to insert the device.The catheter was replaced with one from another manufacturer.There was no difficulty placing the replacement device.The patient did not require hospitalization/prolonged hospitalization due to this occurrence.

Event Description

No additional information regarding patient and/or event details 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.Investigation ¿ evaluation: agility logistics reported an event where catheter flow was obstructed 12 hours after placement.The complaint device was reported to be a radial artery pressure monitoring set (rpn: c-pms-400-ra, lot number 13454971).The device was being used for blood pressure monitoring.It was placed in the radial artery access in the wrist.Seldinger technique was being used for placement of the device.During the placement there was difficulty advancing the catheter over the guide wire and into the skin.It was reported that there was bending between the ¿catheter and the fixation butterfly¿ causing obstruction with very high frequency.This obstruction occurred despite the use of proper insertion and fixation techniques.On (b)(6) 2021, the device was removed and replaced without difficulty using a competitor¿s catheter.Reviews of the documentation including the complaint history, device history record, instructions for use (ifu) and quality control procedures of the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examinations could be conducted.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to assure functionality and device integrity prior to shipping.A review of the device history record (dhr) for lot 13454971 found no related nonconformances that could have contributed to the reported failure mode.It should be noted that no other complaints were associated with this lot number.Cook was unable to review product labeling, as the radial artery pressure monitoring set is not supplied with an ifu.The information provided upon review of complaint file, device history record, complaint history and quality control documents do not provide evidence that the device was manufactured out of specification or to suggest items in the lot or similar devices in the field or in house are nonconforming.Based on the information provided, no returned product and the results of our investigation, a definitive cause for the failure could not be established.It is not possible to rule out patient anatomy or the medical procedure as a cause of this event.The appropriate personnel have been notified.Per the risk assessment no further action is required.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.

• Brand Name: RADIAL ARTERY PRESSURE MONITORING SET
• 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: 12421085
• MDR Text Key: 269773365
• Report Number: 1820334-2021-02102
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00827002020924
• UDI-Public: (01)00827002020924(17)230927(10)13454971
• 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,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2023
• Device Model Number: N/A
• Device Catalogue Number: C-PMS-400-RA
• Device Lot Number: 13454971
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2020
• 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