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

Catalog Number	KCFW-6.0-35-70-RB-HFANL1-HC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Laceration(s) (1946); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted as a cautionary mean, as the device is not intended to be used on canines.(b)(4).The event is currently under investigation.
Event or Problem Description
During the procedure, a wire exchange was used to place a 6fr flexor check-flo introducer with minimal resistance; however it was unable to be passed beyond the distal abdominal aorta.The 6fr check-flo introducer was removed however the introducer unraveled during removal and a hemorrhage from the femoral artery was noted.A portion of the patient's femoral artery was lacerated and the intimal lining of the patient's femoral artery was noted on the device upon removal.No section remained inside the patient's body.The procedure was able to be completed with small introducer without further incident.Due to the laceration and profuse hemorrhaging, the patient became hypotensive and unstable.During closure, deeper dissection was required to retrieve the lacerated femoral artery resulting in possible damage to the femoral nerve.Complications led to a need for a larger incision than intended, increased surgical time, prolonged recovery time, and extreme discomfort upon recovery.This report is being submitted as a cautionary mean, as the device is not intended to be used on canines.
Additional Manufacturer Narrative
This report is being submitted as a cautionary mean, as the device is not intended to be used on canines.(b)(4).Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), trends, quality control and visual inspection of the returned device was conducted during the investigation.One used/damaged (b)(4) was returned for investigation.The tubing material had separated approximately 61.3 cm from the hub.There was exposed coiling (in tact) followed by 8 cm of sheath tubing.Prior to the exposed coils, the last 1.5 cm of the proximal segment contained stretched coiling inside the tubing.Also, there was a kink in the sheath tubing 51 cm from the hub.A document based investigation evaluation was also performed.Review of device history record 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.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: sheath removal instructions "insert the introducer dilator over the wire into the sheath.Withdraw the sheath and dilator as a unit." the ifu also includes the following warnings/precautions, "before withdrawing the sheath through tortuous anatomy, insert the introducer dilator to avoid possible breakage.Do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt." based on the information provided, device examination and the results of our investigation, a definitive root cause could not be determined.It is possible that the device was manufactured with an insufficient bond melt.In regards to the surgical procedure, the device may have been too large in relation to the diameter of patient's arteries.It was mentioned that use of an 8 fr device had been attempted prior to the 6 fr but was too large; when using the 6 fr device, it was not able to be passed beyond the distal abdominal aorta and a smaller introducer was used to complete the procedure.Also, when removing the 6 fr device from the patient, only a guide wire was mentioned to be in place.Therefore, not using a dilator during removal could have contributed to the event.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
During the procedure, a wire exchange was used to place a 6fr flexor check-flo introducer with minimal resistance; however it was unable to be passed beyond the distal abdominal aorta.The 6fr check-flo introducer was removed however the introducer unraveled during removal and a hemorrhage from the femoral artery was noted.A portion of the patient's femoral artery was lacerated and the intimal lining of the patient's femoral artery was noted on the device upon removal.No section remained inside the patient's body.The procedure was able to be completed with small introducer without further incident.Due to the laceration and profuse hemorrhaging, the patient became hypotensive and unstable.During closure, deeper dissection was required to retrieve the lacerated femoral artery resulting in possible damage to the femoral nerve.Complications led to a need for a larger incision than intended, increased surgical time, prolonged recovery time, and extreme discomfort upon recovery.This report is being submitted as a cautionary mean, as the device is not intended to be used on canines.

• 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: 5519310
• Report Number: 1820334-2016-00176
• Device Sequence Number: 16207729
• Product Code: DYB
• UDI-Device Identifier: 00827002562264
• UDI-Public: (01)00827002562264(17)180811(10)6110696
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: KCFW-6.0-35-70-RB-HFANL1-HC
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2016
• Supplement Report FDA Received Date: 12/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 1 YR
• Patient Weight: 3