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	07/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number: re-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
As reported, during an endovascular treatment procedure for peripheral artery disease, the tip of a flexor ansel guiding sheath frayed.The device was unable to be inserted into the patient's body, and after several attempts, the device reportedly frayed.Sharp edges were not noted.The puncture site was reportedly calcified.A cook 7 french flexor shuttle was used to complete the procedure, which included pre-ballooning and stent placement.There has been no report that any part of the device remained in the patient's body, that the patient required any additional procedures, or that the patient experienced any adverse effects due to this event.
Additional Manufacturer Narrative
Additional information: investigation - evaluation.Reviews of the complaint history, device history record, drawings, instructions for use (ifu), manufacturer¿s instructions, and quality control procedures 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, drawings, and quality control procedures were conducted, and no gaps were discovered.Through these reviews, cook has confirmed that sufficient inspection activities are in place to identify this failure mode prior to distribution.Moreover, an ifu is provided with this 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 this event cannot be traced to the device but to the patient¿s condition.Reportedly, the access site was severely calcified during insertion attempt.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 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.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 since the last report was submitted.
Additional Manufacturer Narrative
This mdr is being submitted as having information not previously reported.Additional complaint investigation and record remediation was not performed.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/event information has been received since the previous medwatch report was submitted.

• 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: 8777040
• Report Number: 1820334-2019-01659
• Device Sequence Number: 14119910
• Product Code: DYB
• UDI-Device Identifier: 00827002299993
• UDI-Public: (01)00827002299993(17)220312(10)9584468
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 05/14/2020

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: 03/12/2022
• Device Model Number: G29999
• Device Catalogue Number: KSAW-7.0-18/38-55-RB-ANL1-HC
• Device Lot Number: 9584468
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 07/26/2019; 04/07/2020; 05/14/2020
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 07/30/2019; 04/07/2020; 05/14/2020
• 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: VAIABAHN 7MM -15CM (GORE MEDICAL); VAIABAHN 7MM -15CM (GORE MEDICAL)
• Patient Age: 80 YR