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

Model Number	N/A
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
A flexor ansel guiding sheath was used in a lower extremity angioplasty of the superficial femoral artery (sfa).It was reported that, another manufacturers balloon was re-inserted into the left leg of the patient for additional prolonged low-pressure angioplasty.There was some resistance re-inserting the balloon; however, when moderate force was used the balloon advanced.As the balloon was advancing the hub detached from the shaft of the sheath and remained in the patient.The hub was removed and a 9 french sheath and a snare were slid over the wire.The 9 french sheath and fractured flexor sheath were removed as a unit.The 9 french sheath was re-inserted to finish the case.Two non-cook vascular closure devices were used to close the insertion site; however, they did not work on the 9 french hole and pressure had to be held for 30 minutes.No additional adverse events occurred.
Additional Manufacturer Narrative
Additional information: concomitant medical products.Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, and quality control data was conducted during the investigation.The complaint device was not returned; therefore, no physical examination could be performed.However, a document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.An image of the failure was provided and reviewed.The image shows the sheath material to be separated near the hub with coils extending from the proximal end of the sheath.There appears to be kink approximately 1cm from the proximal end of the sheath.The connector cap of the sheath is somewhat translucent nature which shows the flare to be seated inside the connector cap cavity.Based on the available information, the root cause was determined to be related to user technique.The technique during insertion into the body contributed to this event since the physician experienced resistance when reinserting the balloon but yet he applied moderate force to advance the balloon into the sheath, whereas the ifu clearly states that ¿all instruments or catheters used with this product should move freely through the valve and sheath.Damage to the valve/introducer may result when the fit is tight.Do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt.¿ measures have been initiated to address this failure mode.The appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: FLEXOR ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6830300
• Report Number: 1820334-2017-02761
• Device Sequence Number: 19210337
• Product Code: DYB
• UDI-Device Identifier: 00827002299818
• UDI-Public: (01)00827002299818(17)200613(10)7985930
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 11/10/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: KCFW-5.0-18/38-45-RB-ANL1-HC
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/22/2017
• Supplement Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 08/30/2017
• Supplement Report FDA Received Date: 11/10/2017
• 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