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

Model Number	G48007
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pma/510(k) number: k171275.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As discovered on the fda maude database, during a cardiac catheterization procedure involving a patient of unknown age and gender, a micropuncture transitionless stiffened cannula access set wire separated in the patient.Reportedly, several attempts were made with different wire guides to obtain access in the femoral artery in order to place an unknown 6 french sheath into the iliac "distribution".Because the wires were unable to pass through the right iliac artery, the decision was made to attempt access in the left side using ultrasound.After an unknown catheter was advanced, the needle was unable to be removed.When the user pulled on the outer part of the wire guide, it sheared off and went into the left profunda artery.Flow limitation was not noted.The patient was reportedly transferred to another facility for possible attempted removal of the separated portion of the wire guide.Further details of the event are unable to be obtained, as there is no contact information available from the maude report.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Initial report: as discovered on the fda maude database, during a cardiac catheterization procedure involving a patient of unknown age and gender, a micropuncture transitionless stiffened cannula access set wire separated in the patient.Reportedly, several attempts were made with different wire guides to obtain access in the femoral artery in order to place an unknown 6 french sheath into the iliac "distribution".Because the wires were unable to pass through the right iliac artery, the decision was made to attempt access in the left side using ultrasound.After an unknown catheter was advanced, the needle was unable to be removed.When the user pulled on the outer part of the wire guide, it sheared off and went into the left profunda artery.Flow limitation was not noted.The patient was reportedly transferred to another facility for possible attempted removal of the separated portion of the wire guide.Investigation - evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturer¿s instructions, and the quality control procedures of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.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.Furthermore, reviews of the manufacturer¿s instructions, drawings, specifications, and quality control procedures were conducted, and no gaps were discovered.There is evidence to indicate that the device was manufactured to specifications.An ifu is provided with this device, which states, ¿this product is intended for use by physicians trained and experienced in diagnostic and interventional techniques.Standard techniques for placement of vascular access sheaths should be employed.¿ the ifu goes on to note, ¿when inserting, manipulating or withdrawing a device through an introducer, always maintain introducer position.¿ and finally, ¿do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt.¿ based on the information provided and no product returned, investigation has concluded that a root cause for this event could not be established.However, a possible reason for the reported failure may include the difficulty encountered with the patient¿s anatomy.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or 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
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9349610
• Report Number: 1820334-2019-02930
• Device Sequence Number: 16732271
• Product Code: DYB
• UDI-Device Identifier: 00827002480070
• UDI-Public: (01)00827002480070(17)220723(10)9897811
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/23/2022
• Device Model Number: G48007
• Device Catalogue Number: MPIS-501-10.0-SC-NT-SST
• Device Lot Number: 9897811
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other