MAUDE Adverse Event Report: COOK INC PERFORMER MULLINS GUIDING SHEATH; DYB INTRODUCER, CATHETER

Model Number G08133

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Date 04/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Pma/510(k) number = pre-amendment.Investigation - evaluation: a review of the complaint history, device history record, instructions for use (ifu), and quality control of the device was conducted during the investigation.Photos of the complaint device were in the sealed package were supplied however, the 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.The product is supplied with an ifu which provides the following information to the user related to the reported failure mode: how supplied: "do not use the product if there is doubt as to whether the product is sterile.Upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, no product returned and the results of our investigation, it has been concluded manufacturer deficiency has contributed to this event.Appropriate measures have been initiated to address this failure mode.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

Event Description

It was reported, after receipt of a roadrunner the firm hydrophilic wire guide at the distribution facility, a piece of hair was observed inside of the sealed primary packaging.This was observed during initial inspection and was not used for patient care.Per the initial reporter, the complaint device will not be returned to the manufacturer to aid in the investigation.

• Brand Name: PERFORMER MULLINS GUIDING SHEATH
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 8654207
• MDR Text Key: 146511857
• Report Number: 1820334-2019-01292
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002081338
• UDI-Public: (01)00827002081338(17)210822(10)NS9112024
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/22/2021
• Device Model Number: G08133
• Device Catalogue Number: RCFW-8.0-38-63-RB-MTS
• Device Lot Number: NS9112024
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1