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

Model Number	G07856
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Blood Loss (2597); No Code Available (3191)
Date of Event	05/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, or unavailable.(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, during endovascular aneurysm repair for an aortic aneurysm, the physician noted blood loss after inserting the flexor introducer sheath into the external iliac artery.Reportedly, access was gained from the left external iliac artery using an ipsalateral approach via a micropuncture set and perclose device (abbott).Patient's anatomy upon insertion was minimally tortuous.The initial perclose device (abbott) was removed and the 8fr flexor introducer sheath was placed using a bentson wire (cook medical).Resistance was felt when the physician attempted to remove the complaint device over the wire guide.The physician held significant pressure on the patient's abdomen and continued to pull back on the complaint device.The hub separated, leaving the sheath tubing and wire guide in the patient's artery.The patient began losing blood through the 8fr flexor introducer sheath lumen, and manual pressure was held at the access site.A coda balloon catheter (cook medical) was placed, via another access site, to successfully control the bleeding.A cut-down procedure was then performed to complete the aortic aneurysm repair procedure and retrieve the sheath and wire guide with forceps.No portion of the complaint device remained in the patient's anatomy.No blood products were required.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 adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the dimensional verification, complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the sheath of the device was separated from the hub.Biomatter was present in and on the hub of the device.The flare also appeared out-of-round.There was no sheath tubing material present in the hub.The sheath flare passed through the large lumen, but didn't pass through the small lumen of the flare inspection gauge.The inner diameter of the connecting cap was found to be within specification.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.Measures are being conducted to address this failure mode.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.
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
Correction: d1, d4, g5, h4.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 7570454
• Report Number: 1820334-2018-01638
• Device Sequence Number: 10807819
• Product Code: DYB
• UDI-Device Identifier: 00827002078567
• UDI-Public: (01)00827002078567(17)210430(10)8850364
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: G07856
• Device Catalogue Number: KCFW-8.0-38-RB
• Device Lot Number: 8850364
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 08/10/2018; 03/30/2020
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 08/16/2018; 03/31/2020
• 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: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR