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

Model Number	G56278
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 reported that during an unspecified procedure, the valve portion of the flexor high-flex ansel guiding sheath leaked as the catheter was being introduced.After replacing the sheath, the balloon was successfully introduced.No information was provided regarding manufacturer of the catheter.According to the initial reporter, the patient did not experience any adverse effects as a result of this event.Additional information regarding event details and complaint device return 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, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the dilator was able to be fully advanced into the sheath when inserted proximally.The check-flo assembly was examined for secure fittings and proper disc position, and was determined to be within specification.The sheath was also checked for leakage, and the device did not leak.Additionally, 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 showed the lot was released meeting all finished goods release criteria.It should be noted there were no 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.The failure mode could not be replicated or observed in testing.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.
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
B5: clarification was received from the initial reporter stating a "cook.035 155mm j wire" was being utilized through the valve, not a "catheter" as was initially reported.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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.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.

• 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: 7491670
• Report Number: 1820334-2018-00931
• Device Sequence Number: 13879270
• Product Code: DYB
• UDI-Device Identifier: 00827002562783
• UDI-Public: (01)00827002562783(17)210126(10)8538884
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/26/2020

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: 01/26/2021
• Device Model Number: G56278
• Device Catalogue Number: KCFW-10.0-35-45-RB-HFANL0-HC
• Device Lot Number: 8538884
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/12/2018
• Supplement Date Received by Manufacturer: 05/21/2018; 06/19/2018; 03/25/2020
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 05/30/2018; 06/29/2018; 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1