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

Model Number	N/A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Occupation: chief technician.Pma/510(k) #: not exempt, pre-amendment.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that the catheter in a femoral artery pressure monitoring set was found to be broken and leaking.The procedure performed on the patient was a femoral artery cannulation.The complaint device did not make patient contact.As reported, there were no adverse effects experienced by the patient due to this occurrence.Additional information regarding event details has been requested but is currently unavailable.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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 or Problem Description
Additional information was provided on 12nov2019 stating that the leaking was discovered during the procedure and the catheter was broken at the distal part.The procedure was completed by using another catheter.
Event or Problem Description
No additional patient/event details have been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Correction: h6 - device code: fracture (1260).Investigation ¿ evaluation: a review of the complaint history, device history record, quality control, and specifications, as well as a visual inspection of the returned device were conducted during the investigation.One femoral artery pressure monitoring set was returned for inspection.The visual inspection of the complaint device noted that the catheter was cracked at the hub.There is no evidence to suggest that the device was not manufactured to specification.Additionally, a document based investigation evaluation was performed.A review of the device master record found that proper procedures are in place to identify and prevent this failure mode prior to device distribution.A review of the device history records for the set lot and the catheter component lots found no nonconformances related to the failure mode.A database search found no other complaints reported for this device lot.Therefore, there is no evidence to suggest that there is any nonconforming product in house or out in the field.Based on the information provided, inspection of the returned product, and the results of the investigation, a definitive cause was not established.The appropriate personnel have been notified.Per the quality engineering risk assessment, no further action is required.Cook 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.

• Brand Name: FEMORAL ARTERY PRESSURE MONITORING SET
• Common Device Name: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9310340
• Report Number: 1820334-2019-02838
• Device Sequence Number: 2360678
• Product Code: DQO
• UDI-Device Identifier: 00827002021792
• UDI-Public: (01)00827002021792(17)220326(10)NS9622204
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/26/2022
• Device Model Number: N/A
• Device Catalogue Number: C-PMS-500-FA
• Device Lot Number: NS9622204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 11/12/2019; 01/06/2020
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 12/10/2019; 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 79