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

Model Number	G29996
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/10/2018
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
Prior to an unknown procedure, a flexor ansel guiding sheath was noted to have a "crack" in the tip of the device.Another similar device was used to successfully complete the procedure.This device was observed to be cracked upon opening the package.It did not make patient contact and no adverse events have been reported.The customer has stated the device will not be returned.Pictures of the device have been requested; however, none are available at this time.
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: a review of the complaint history, device history record, 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.Additionally, the device in question was note returned.However, a like device was returned from the same facility from the same lot and will be used as a representative device.One unused ksaw-6.0-18/38-55-rb-anl1-hc was returned for investigation sealed in its original packaging.The device includes a 6.0fr sheath, a dilator with a.018 tapered tip, and a dilator with a.038 tapered tip.All three components were examined for surface defects/damage as well as tip damage, however no damage of any kind was noted on any of the components.Furthermore, an ifu is provided with the device, which states ¿upon removal from package, inspect the product to ensure no damage has occurred." moreover, a review of the manufactures instructions and quality control procedures was completed and revealed no gaps.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be established.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.
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 additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 7995733
• Report Number: 1820334-2018-03184
• Device Sequence Number: 11145819
• Product Code: DYB
• UDI-Device Identifier: 00827002299962
• UDI-Public: (01)00827002299962(17)210719(10)9031558
• 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: health professional,user faci
• 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: 07/19/2021
• Device Model Number: G29996
• Device Catalogue Number: KSAW-6.0-18/38-55-RB-ANL1-HC
• Device Lot Number: 9031558
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/12/2018
• Supplement Date Received by Manufacturer: 02/06/2019; 03/17/2020; 05/14/2020
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 02/08/2019; 03/17/2020; 05/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1