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

Model Number	G56220
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2019
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 patient (demographics unknown) was undergoing an unspecified procedure.The physician inserted a flexor high-flex ansel guiding sheath over a roadrunner wire (cook).As soon the sheath was inserted into the patient's anatomy, up and over the bifurcation in the common femoral artery, the sheath was noted to be "back-bleeding".The target was to have been the superficial femoral artery.As soon as the back bleeding was noted, the complaint sheath was removed and replaced with a new flexor high-flex ansel guiding sheath to successfully complete the procedure.Estimated blood loss was not provided; however, the patient did not need a transfusion or additional procedures as a result of this event.The patient did not experience any adverse effects.
Additional Manufacturer Narrative
Investigation - evaluation.Reviews of the complaint history, device history record, documentation, instructions for use (ifu), manufacturer¿s instructions, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one sheath and dilator were returned separately for investigation.There was slight biomatter along the devices.There was no visible damage to the device; however, there was confirmed leakage from the check-flo valve.Upon examining the silicone disc, the split appeared correct; however, there was a small pinhole in the silicone disc near the opening.This hole has been confirmed as the cause for the leakage.It should be noted that this hole appeared to be cause from some form of damage, possible forced entry.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 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 this device, which lists the appropriate warnings, precautions and instructions for use.The ifu also contains the following precautions: ¿the maximum diameter of the instrument or catheter to be introduced should be determined to ensure its passage through the introducer.All instruments or catheters used with this produce should move freely through the valve and sheath.Damage to the valve/introducer may result when fit is tight.¿.Based on the information provided and the examination of the returned product, investigation has concluded that this event can be traced to the user and unintended use error.During the device evaluation, the silicone disc was noted to have a hole likely caused by excessive force.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 to report.

• 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: 8633385
• Report Number: 1820334-2019-01251
• Device Sequence Number: 1941736
• Product Code: DYB
• UDI-Device Identifier: 00827002562202
• UDI-Public: (01)00827002562202(17)220214(10)9522494
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2020

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: 02/14/2022
• Device Model Number: G56220
• Device Catalogue Number: KCFW-5.0-35-70-RB-HFANL0-HC
• Device Lot Number: 9522494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 07/08/2019; 04/08/2020
• Initial Report FDA Received Date: 05/22/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PARK SHEATH.; PARK SHEATH