MAUDE Adverse Event Report: COOK INC MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET; DYB INTRODUCER, CATHETER

Catalog Number	MPIS-401-10.0-SC-SST
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/23/2018
Type of Reportable Event	Malfunction
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
It was reported that during a femoral endovascular aneurysm repair, the micropuncture transitionless stiffened cannula access set became caught on the patient's anatomy in the groin region.A piece of the complaint device sheared off into the patient's artery.Reportedly, the piece remains in the patient's vasculature with no plans for retrieval.According to the initial reporter, the patient did not experience any additional adverse effect as a result of this occurrence, and "is doing fine." additional information regarding event details, patient anatomy and outcome has been requested, but is not available at this time.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, and specifications of the device was 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 is no evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.Measures are being conducted to address this failure mode.We will continue to monitor for similar complaints.Per the risk assessment, no further action is required.

• Brand Name: MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7502682
• Report Number: 1820334-2018-01262
• Device Sequence Number: 11215984
• Product Code: DYB
• UDI-Device Identifier: 00827002480025
• UDI-Public: (01)00827002480025(17)201210(10)8432606
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2018

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 Catalogue Number: MPIS-401-10.0-SC-SST
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 06/04/2018
• 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: Other
• Patient Age: 57 YR