MAUDE Adverse Event Report: COOK INC FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH; DYB INTRODUCER, CATHETER

Model Number	G49043
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number = pre-amendment.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 originally reported, the flexor high-flex ansel guiding sheath broke.Additional information had been requested.Upon receipt of additional information provided to the manufacturer on 01/18/2019, it was learned the end of the device broke off upon removal from the patient's anatomy.Access was gained via the patient's leg in a contralateral approach.The anatomy was not tortuous or calcified, and the type of procedure was not specified.It is not known what other devices were utilized through the flexor high-flex ansel guiding sheath, however it was provided that during removal of the complaint device over an unspecified guide wire, the end of the flexor high-flex ansel guiding sheath broke off.No part of the device remained inside the patient's anatomy.According to the company representative, the patient did not require additional procedures due to this event.Additionally, the patient did not experience any adverse effects.The device was discarded at the user facility; therefore, it is not available to aid the manufacturer's investigation.
Additional Manufacturer Narrative
Investigation/evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufactures instructions, quality control, and specifications of the device was 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.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, a review of the manufactures instructions and quality control procedures was conducted, and no gaps were discovered.Moreover, an ifu is provided with the device, which warns to reinsert the dilator prior to removal.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be traced to the device.The root cause likely lies with an adverse event related to the procedure as there is no evidence that the dilator was reinserted prior to the removal attempt.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Measures are being conducted to address this failure mode.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.
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: g5 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 HIGH-FLEX ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8274966
• Report Number: 1820334-2019-00226
• Device Sequence Number: 1306938
• Product Code: DYB
• UDI-Device Identifier: 00827002490437
• UDI-Public: (01)00827002490437(17)210625(10)8975187
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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): 03/17/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/25/2021
• Device Model Number: G49043
• Device Catalogue Number: KCFW-7.0-35-55-RB-HFANL1-HC
• Device Lot Number: 8975187
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/18/2019
• Supplement Date Received by Manufacturer: 01/30/2019; 03/17/2020
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 02/03/2019; 03/17/2020
• 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: PREVIOUSLY STATED