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

Model Number	G56279
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number = preamendment.Device evaluation begun, but is not yet complete.(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 that during an unspecified procedure, the flexor high-flex ansel guiding sheath was leaking.Additional information regarding event details, patient anatomy and outcome has been requested, but is not available at this time.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), quality control, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.The visual inspection of the returned device did not reveal any signs of damage; however, when a leak test of the device was performed, the device did leak out of the end of the catheter.Additionally, a document based investigation evaluation was performed.A review of the device history record showed 3 nonconforming events which could contribute to this failure mode; however, all non-conforming devices were reworked or scrapped.It should be noted there were two 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.We will continue to monitor for similar complaints.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.
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.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: 7367068
• Report Number: 1820334-2018-00662
• Device Sequence Number: 1950231
• Product Code: DYB
• UDI-Device Identifier: 00827002562790
• UDI-Public: (01)00827002562790(17)200613(10)7985955
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2020

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: 06/13/2020
• Device Model Number: G56279
• Device Catalogue Number: KCFW-12.0-35-45-RB-HFANL0-HC
• Device Lot Number: 7985955
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 03/29/2018; 03/24/2020
• Initial Report FDA Received Date: 03/23/2018
• Supplement Report FDA Received Date: 04/23/2018; 03/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1