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 Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/06/2021

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.It is unknown if the device will be returned.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 cerebral angiogram via access in the radial artery, the wire included in a micropuncture transitionless stiffened cannula access set separated.The patient was taken to the cath lab for the angiogram two days after being admitted to the hospital for a stroke (on day 3 of admission).During the procedure, the micropuncture wire separated in the soft tissue versus the right radial artery, near the puncture site, and was unable to be removed.Radial access was aborted and access was obtained in the groin.The radial pulse was present and the right ulnar artery was patent.After the procedure, a vascular surgeon was consulted.The patient was taken to surgery the following day (day 4 of admission) for removal of the wire fragment and repair of the right radial artery.The patient tolerated the procedure well and once stable, was discharged to home the next day (day 5 of admission).

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: d4- based on customer sales data, the product lot is either 14178062 (udi: (b)(4), or 14353689 (udi: (b)(4).Event summary as reported, during a cerebral angiogram via access in the radial artery, the wire included in a micropuncture transitionless stiffened cannula access set separated.The patient was taken to the cath lab for the angiogram two days after being admitted to the hospital for a stroke (on day 3 of admission).During the procedure, the micropuncture wire separated in the soft tissue versus the right radial artery, near the puncture site, and was unable to be removed.Radial access was aborted and access was obtained in the groin.The radial pulse was present and the right ulnar artery was patent.After the procedure, a vascular surgeon was consulted.The patient was taken to surgery the following day (day 4 of admission) for removal of the wire fragment and repair of the right radial artery.The patient tolerated the procedure well and once stable, was discharged to home the next day (day 5 of admission).Investigation - evaluation reviews of the instructions for use, manufacturing instructions, and quality control procedures were conducted during the investigation.No device was returned for investigation.A document-based investigation evaluation was performed for potential lots 14178062 and 14353689.No related non-conformances were recorded, and there have been no other reported complaints for either 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 caution, ¿do not attempt to insert or withdraw the wire guide and/ or introducer if resistance is felt,¿ and, ¿withdrawal or manipulation of the distal spring coil portion of the mandril wire guide through needle tip may result in breakage.¿ based on the available information, cook has concluded that a component failure unrelated to manufacturing or design deficiencies contributed to this incident.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: 14780169
• MDR Text Key: 295024373
• Report Number: 1820334-2022-01103
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MPIS-502-10.0-SC-NT-U-SST
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian