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

Model Number G48008

Device Problems Material Separation (1562); Unraveled Material (1664)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/03/2020

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, while using a micropuncture transitionless stiffened cannula access set, the access wire shredded.It did not break, but it did uncoil and become elongated.A small portion of the tip remained inside of the patient.The access site was noted to be very calcified.And there was resistance during insertion/ removal of the device.No additional procedures were required due to this occurrence.No adverse effects to the patient were reported due to this occurrence.

Event Description

Information was available and inadvertently omitted from the initial mdr.Access was obtained in the left femoral artery.The wire was removed through the access needle.

Manufacturer Narrative

Summary of event: as reported, while using a micropuncture transitionless stiffened cannula access set, the access wire uncoiled and elongated.A small portion of the separated tip remained inside of the patient.The femoral access site was noted to be very calcified, and resistance was reported during insertion and removal of the device.The wire was removed through a needle.No additional procedures were required due to this occurrence.No adverse effects to the patient were reported due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.From the analysis of the returned device, elongation was noted, and the distal solder weld was missing.No additional damage was noted.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.From the information provided upon review of the dmr, dhr, dhf, ifu, and returned device, cook concluded that the device was manufactured to specification, and that there are no nonconforming devices in-house or out in the field.The product ifu warns: "do not withdraw the wire guide through the introducer needle; breakage may result.If the wire guide tip must be withdrawn while the needle is inserted, remove both the needle and the wire as a unit.¿ cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that unintended use error contributed to the failure mode.The customer stated that the device was removed from the needle, and the patient¿s anatomy was highly calcified.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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: 10983508
• MDR Text Key: 220918231
• Report Number: 1820334-2020-02269
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002480087
• UDI-Public: (01)00827002480087(17)231031(10)13526452
• Combination Product (y/n): N
• PMA/PMN Number: K171275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: G48008
• Device Catalogue Number: MPIS-501-10.0-SC-NT-U-SST
• Device Lot Number: 13526452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR