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

Model Number	G56221
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the initial reporter, the device will not be returned.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 a critical limb ischemia (cli) intervention procedure (including laser atherectomy, shockwave angioplasty, and use of an unknown drug coated balloon in the superficial femoral artery), a flexor high-flex ansel guiding sheath leaked at the check-flo valve.Access was obtained in the groin and a contralateral approach was used for the procedure.Another manufacturer's wire guide was used with the device.The patient's anatomy was described as "somewhat calcified".The device continued to be used after the leak was observed, as it was reported that the device did not leak when some devices were in the introducer.The procedure was completed successfully and the device was removed.The vessel was closed with an unknown closure device.The physician reports total blood loss as a result of the event as 10 ml.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, and quality control was conducted during the investigation.The complaint device was not returned for this instance.Customer images were received.Without physical examination, a conclusion cannot be made regarding the reported event.If the device for this instance is returned, the investigation will be reopened.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 of the device and component lot shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.This device was shipped with instructions for use "introducers," which lists the appropriate warnings, precautions and instructions for use.The ifu 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 product should move freely through the valve and sheath.Damage to the valve/introducer may result when fit is tight.The complaint has been confirmed through customer testimony and the customer photos.Based on the information provided and no product returned, investigation has concluded a cause for the reported event cannot 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 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
Correction: g5.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: 8245565
• Report Number: 1820334-2019-00078
• Device Sequence Number: 16788032
• Product Code: DYB
• UDI-Device Identifier: 00827002562219
• UDI-Public: (01)00827002562219(17)210727(10)9050967
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2020

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: 07/27/2021
• Device Model Number: G56221
• Device Catalogue Number: KCFW-6.0-35-70-RB-HFANL0-HC
• Device Lot Number: 9050967
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/03/2019
• Supplement Date Received by Manufacturer: 04/11/2019; 03/20/2020
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 04/15/2019; 03/20/2020
• 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: ABBOTT COMMAND ES WIRE,COOK CXI,ABBOTT ARMADA 14.