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

Catalog Number	MPIS-401-NT-SST
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pma/510(k) number: pre-amendment.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 port-o-cath placement procedure, the micropuncture transitionless access set "broke" during cannulation through the skin.The complaint device was removed and another cannulation was performed.No adverse effects were reported.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 dimensional verification, complaint history, device history record, documentation, quality control, specifications, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.The inspection of the returned device confirmed that the inner dilator was bent approximately 50 degrees.The bend began approximately 2.5 cm from the proximal hub.The outer sheath was separated at a distance of 1.8 cm from the proximal hub, with stretching noted at the point of separation.The separated segment was measured to be 8.3 cm in length.Accordion-like damage was observed at the distal tip of the device.There were also surface marks on the shaft of the outer sheath.Additionally, 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 showed the lot was released meeting all finished goods release criteria.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, 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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: MICROPUNCTURE TRANSITIONLESS ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7496003
• Report Number: 1820334-2018-01220
• Device Sequence Number: 1339842
• Product Code: DYB
• UDI-Device Identifier: 00827002479425
• UDI-Public: (01)00827002479425(17)200131(10)7638031
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 07/10/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MPIS-401-NT-SST
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/17/2018
• Supplement Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1