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

Catalog Number MPIS-502-10.0-SC-NT-U-SST

Device Problems Bent (1059); Material Separation (1562); Difficult to Advance (2920)

Patient Problem No Code Available (3191)

Event Date 03/07/2018

Event Type  Injury  

Manufacturer Narrative

The pma/510(k) number = k133114.Device evaluation begun, but is not yet complete.(b)(4).This report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that while accessing the patient's artery for a lower extremity angiogram, once the micropuncture transitionless stiffened cannula access set needle was inside of the artery, the set wire guide was inserted.As the wire guide was being manipulated, the tip broke off inside of the patient's anatomy.The stiffened cannula introducer that goes over the wire guide was inserted and the physician made a skin knick to advance.Difficulty was encountered while advancing the introducer and it bent a few times, but the physician was able to advance it.Upon removal of the introducer, the tip was within the introducer; however, when the introducer was pulled out, the tip remained inside the patient on the needle track.The tip was then able to be grabbed and pulled out of the patient.A new set was opened and utilized to successfully complete the procedure.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information regarding event details and patient anatomy has been requested, but is not available at this time.

Manufacturer Narrative

Device evaluation begun, but is not yet complete.It was reported that while accessing the patient's artery for a lower extremity angiogram, once the micropuncture transitionless stiffened cannula access set needle was inside of the artery, the set wire guide was inserted.As the wire guide was being manipulated, the tip broke off inside of the patient's anatomy.The stiffened cannula introducer that goes over the wire guide was inserted and the physician made a skin knick to advance.Difficulty was encountered while advancing the introducer and it bent a few times, but the physician was able to advance it.Upon removal of the introducer, however, metal stiffening cannula within the external tubing component of the device remained inside the patient on the needle track.The cannula was then able to be grabbed and pulled out of the patient.A new set was opened and utilized to successfully complete the procedure.According to the initial reporter, no remnants of the device was left in the patient.The patient did not experience any adverse effects due to this occurrence.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Manufacturer Narrative

Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, drawing, quality control, specifications, instructions for use (ifu), and manufacturing instructions and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the stiffening cannula was separated from the inner dilator.The dilator plastic portion connected to the hub was 12cm in length, with a 30 degree bend at a distance of 2cm from the hub of the device.The stiffening cannula was 12.5 cm in length, and had a 12 degree bend that began 7cm from the proximal end.Additionally, a document based investigation evaluation was performed.A review of the device history record shows 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 quality engineering risk assessment, no further action is required.

• Brand Name: MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7384725
• MDR Text Key: 103923755
• Report Number: 1820334-2018-00722
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002355514
• UDI-Public: (01)00827002355514(17)201227(10)8474061
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MPIS-502-10.0-SC-NT-U-SST
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention