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

Model Number	N/A
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Code Available (3191)
Date of Event	12/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
The customer reported that, upon the attempted removal from the patient of the radial artery pressure monitoring set catheter, the device became lodged in the patient, and additional surgery was required to remove the lodged portion.The lodged portion was ultimately removed successfully.A voluntary medwatch report (mw5074233) was received on (b)(6) 2018.The report stated, "when removing the catheter, a portion broke off and was retained and required surgical intervention for removal.The device has been received for evaluation; however, as of the date of this report, the investigation is still pending.
Additional Manufacturer Narrative
A review of the complaint history, device history record, documentation, manufacturing instructions, specification, quality control data and visual inspection of the returned device was conducted during the investigation.One device was returned for investigation.The catheter was returned severed 2 mm from the hub.The other catheter measured 4.7 cm in length.The points of separation have a pinched, cut, and pulled to separation.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the device history record found no other non-conformances associated with the complaint device lot number.Additionally, a review of the manufacturer's complaint database found no other complaints associated with the complaint device lot number.Based on the provided information, inspection of returned product]and the investigation, a definitive root cause cannot be established or reported at this time.Per the quality engineering risk assessment, no further action is required.

• Brand Name: RADIAL 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: 7202091
• Report Number: 1820334-2018-00091
• Device Sequence Number: 1174492
• Product Code: DQO
• UDI-Device Identifier: 00827002029309
• UDI-Public: (01)00827002029309(17)200928(10)8254490
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-PMS-251-RA
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/21/2017
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 01/17/2018
• Supplement Report FDA Received Date: 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention