MAUDE Adverse Event Report: COOK INC SINGLE LUMEN PRESSURE MONITORING SET; DQY CATHETER, PERCUTANEOUS

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
510k status: preamendment.(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 the line of the single lumen pressure monitoring set severed from the hub portion of the device, which led to the separated part becoming lodged in the patient's blood vessel.Additional information regarding the event has been requested from the customer, but none has yet been provided.The device is reportedly unavailable for return and evaluation.
Additional Manufacturer Narrative
A review of the complaint history, device history record, drawing, instructions for use, manufacturing instructions and quality control was completed during this investigation.The product was not returned, so physical evaluation could not be performed.The device history record for lot number 7715973 was reviewed and noted no non-conformances that were related to the reported failure mode.Additionally, a search of the manufacturer's complaint database found no other complaint associated with the complaint device lot number (7715973).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.This complaint is confirmed based on the customer's testimony.The ifu does not contain information regarding the failure mode.Based on the provided information a definitive root cause cannot be established at this time.Per a quality engineering risk assessment not further action is required.

• Brand Name: SINGLE LUMEN PRESSURE MONITORING SET
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7214297
• Report Number: 1820334-2018-00152
• Device Sequence Number: 13708637
• Product Code: DQY
• UDI-Device Identifier: 00827002019157
• UDI-Public: (01)00827002019157(17)200301(10)7715973
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• 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-500
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/29/2017
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 01/23/2018
• 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: Life Threatening