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

Model Number G48003

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/05/2022

Event Type  Injury  

Manufacturer Narrative

This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during a coronary angiogram via femoral access, a micropuncture transitionless stiffened cannula access set's sheath separated upon removal from the patient.The femoral arteries were reportedly very calcified and access was described as difficult; however, the user denied meeting resistance upon insertion or removal of the device.The groin was not scarred, and the sheath was not advanced through a previously-placed closure device.A wire was inserted through the sheath and as the user attempted to remove the sheath over the wire, half of the sheath separated in the femoral artery.Vascular physicians were consulted, and a cut-down was performed under general anesthesia; however, the vessels were too calcified to safely clamp the arteries and the procedure was abandoned.Left femoral access was then obtained, and a snare was used to remove the separated fragment under radiology guidance.

Manufacturer Narrative

Event summary: as reported, during a coronary angiogram via femoral access, a micropuncture transitionless stiffened cannula access set's sheath separated upon removal from the patient.The femoral arteries were reportedly very calcified and access was described as difficult; however, the user denied meeting resistance upon insertion or removal of the device.The groin was not scarred, and the sheath was not advanced through a previously-placed closure device.A wire was inserted through the sheath and as the user attempted to remove the sheath over the wire, half of the sheath separated in the femoral artery.Vascular physicians were consulted, and a cut-down was performed under general anesthesia; however, the vessels were too calcified to safely clamp the arteries and the procedure was abandoned.Left femoral access was then obtained, and a snare was used to remove the separated fragment under radiology guidance.Investigation - evaluation: reviews of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control procedures and a visual inspection of the device were conducted during the investigation.Two outer catheters of a used mpis-401-10.0-sc-nt-sst were returned for investigation.The 4fr outer catheter was separated at approximately 5cm from the hub.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which caution, ¿when inserting, manipulating or withdrawing a device through an introducer, always maintain introducer position,¿ and, ¿do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt.¿ based on the available information, cook has concluded patient anatomy contributed to this incident.Access was difficult due to the noted severely calcified vessel.Cook will continue monitoring of similar complaints and has 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 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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 14316519
• MDR Text Key: 292385903
• Report Number: 1820334-2022-00692
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002480032
• UDI-Public: (01)00827002480032(17)241206(10)14396938
• Combination Product (y/n): N
• PMA/PMN Number: K171275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G48003
• Device Catalogue Number: MPIS-401-10.0-SC-NT-SST
• Device Lot Number: 14396938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2021
• 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
• Patient Outcome(s): Required Intervention