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

Model Number N/A

Device Problems Knotted (1340); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A supplemental report will be submitted upon completion.

Event Description

It is alleged that a micropuncture transitionless access set was being used during a procedure and the wire guide was found to be knotted upon removal.It was reported that the wire guide was being removed through the needle provided in the set, when the knots were observed.Upon receiving the product for investigation, material separation was obvious and the knot referred to by the customer was found on near the end of the wire.No adverse events have been reported for this incident.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, device history record, instructions for use, manufacturing instructions, quality control data, and visual inspection of the returned device were conducted during the investigation.One used wire guide was returned for investigation from a micropuncture transitionless access set.Visual inspection showed the device coil was elongated.A separated piece of core wire and coil was also returned.The separated section measured 3.6 cm in length and 0.5 cm of the section was knotted.The distal weld is noted on the separated section.A 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.Review of the device history record shows no nonconforming events which could contribute to this failure mode.One other reported complaint for this lot number was identified.Per the instructions for use, the wireguide within the set is packaged in a wireguide holder that includes a warning label which warns the user against removing the wireguide through the needle.The user reportedly removed the wire through the needle.Based on the provided information, a definitive root cause cannot be established or reported at this time.Per the quality engineering risk assessment, no further action is required.We will notify the appropriate personnel and continue to monitor for similar complaints.

• Brand Name: MICROPUNCTURE TRANSITIONLESS ACCESS SET
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6725238
• MDR Text Key: 80506036
• Report Number: 1820334-2017-02035
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002363335
• UDI-Public: (01)00827002363335(17)200301(10)7716120
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MPIS-501-SST
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• 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