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

Catalog Number	MPIS-401-U
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/07/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
The physician felt resistance when attempting to advance the device over the wire guide.A visual examination of the device confirmed that the sheath separated from the hub.The device was replaced with another one.

• Brand Name: MICROPUNCTURE ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6721658
• Report Number: 1820334-2017-02007
• Device Sequence Number: 16311177
• Product Code: DYB
• UDI-Device Identifier: 00827002074101
• UDI-Public: (01)00827002074101(17)160801(10)4459490
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/18/2017

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-U
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 07/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1