MAUDE Adverse Event Report: COOK INC FLEXOR INTRODUCER SHEATH; DYB INTRODUCER, CATHETER

Model Number	G08867
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Code Available (3191)
Date of Event	04/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
It was reported that during an unspecified procedure, a 6f x 30 cm flexor introducer sheath fractured upon insertion in the patient's aortoiliac bifurcation, leaving a 6 cm piece inside the patient's anatomy.An up and over approach was being utilized.The broken sheath was removed, and replaced with another manufacturer's sheath to contain hemostasis.Patient was then intubated in case of possible open cut down to retrieve the foreign body.Once the patient was intubated, the physician accessed the right external iliac artery using ultrasound guidance.Another manufacturer's 8f x 11 cm sheath was then placed in the artery, followed by using another manufacturer's endovascular snare to retrieve the broken off piece of sheath.The percutaneous foreign body removal was successful and an open cutdown was unnecessary.An angiogram was then performed to check for any remaining foreign bodies, after confirming all foreign bodies had been removed, the right sided 8f sheath was removed and another manufacturer's 6 mm x 2.5 cm stent was placed over the access hole in the right external iliac artery.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any additional adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, manufacturing instructions, and quality control, was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.However, an unused, representative device was evaluated and no issues were found.In addition, a document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Based on the information provided and the results of our investigation, a definitive root cause cannot be determined at this time, however appropriate measures have been initiated to address this failure mode.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.
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
This mdr is being submitted as having information not previously reported.Additional complaint investigation and record remediation was not performed.Blank fields on this form indicate the information is unknown or unavailable.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: FLEXOR INTRODUCER SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7483742
• Report Number: 1820334-2018-01224
• Device Sequence Number: 1544411
• Product Code: DYB
• UDI-Device Identifier: 00827002088672
• UDI-Public: (01)00827002088672(17)210122(10)8526588
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/22/2021
• Device Model Number: G08867
• Device Catalogue Number: KCFW-6.0-38-30-RB
• Device Lot Number: 8526588
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2018
• Supplement Date Received by Manufacturer: 05/23/2018; 03/26/2020
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 05/29/2018; 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ZILVER PTX STENTWIRE; ZILVER PTX STENTWIRE
• Outcome Attributed to Adverse Event: Required Intervention