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

Model Number	G29999
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/07/2019
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 at the conclusion of the investigation or, when additional relevant information becomes available.
Event or Problem Description
It was reported, a (b)(6) female patient with a history of peripheral artery disease was undergoing an unspecified endovascular treatment procedure.Access was gained from the right common femoral artery (cfa) to the lesion at the external iliac artery (eia) with a contralateral , retrograde approach.After puncturing the right cfa, the physician attempted to deliver a flexor ansel guiding sheath to place another manufacturer's stent graft at the lesion located in the eia.The dilator could be inserted into the vessel, but the complaint sheath itself was not able to be inserted.After several attempts to insert the sheath into the patient¿s body, the sheath tip became frayed, though the fray did not have any sharp edges.Finally, the physician inserted a 7fr short sheath instead.After the removal of the short sheath, an equivalent device of the complaint one was successfully inserted into the vessel.The procedure was completed without any problems.The physician commented the calcification at the access site may have contributed to this event.There was no patient adverse effect.The complaint device will not be returned to the manufacturer to aid in the investigation.
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
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation.Reviews of the complaint history, device history record, documentation, instructions for use (ifu), manufacturer¿s instructions, and quality control of the device were 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, reviews of the manufacturer¿s instructions and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with the device, which states "upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided and no product returned, investigation has concluded that a root cause for this event cannot be traced to the device but to patient¿s condition.Reportedly, the patient had noticeable scarring at the access site.We will continue our monitoring of similar complaints and have 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.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 new patient or event information to report.
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.Correction: g5.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 ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8616298
• Report Number: 1820334-2019-01180
• Device Sequence Number: 2293325
• Product Code: DYB
• UDI-Device Identifier: 00827002299993
• UDI-Public: (01)00827002299993(17)211127(10)9335114
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2020

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: 11/27/2021
• Device Model Number: G29999
• Device Catalogue Number: KSAW-7.0-18/38-55-RB-ANL1-HC
• Device Lot Number: 9335114
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2019
• Supplement Date Received by Manufacturer: 07/08/2019; 04/07/2020
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 07/10/2019; 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR