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

Catalog Number KCFW-6.0-38-90-RB-RAABE

Device Problems Difficult to Remove (1528); Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 12/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).This event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

As a (b)(6) male underwent an "abdominal aortagram with runoff and percutaneous transluminal angioplasty (pta) to the right leg," it was reported that a flexor raabe guiding sheath had difficulty being removed and separated inside the patient's anatomy.The access site was in the patient's leg and the device was used with a contralateral approach.Unspecified atherectomy devices, balloons, and wire guides had all been inserted through the guiding sheath prior to the separation, but it is said that a dilator was in place when the physician attempted to remove the complaint device.The patient is also reported to have calcified and tortuous anatomy.As a result of the separation, the patient was transferred to another facility's operating room (or) with surgical capabilities, and the remaining portion of the complaint device was removed.No portion of the complaint device remains in the patient.

Manufacturer Narrative

Per user facility medwatch (b)(4) received on 26feb2018: "arterial sheath sheared off and was retained in right femoral artery.Patient was transferred to another hospital for surgical removal." additional information regarding patient outcome was requested, but is not available at this time.Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), specifications, quality control, and visual inspection of the returned device was conducted during the investigation.A flexor raabe guiding sheath was returned with the dilator inserted.The dilator was removed from the sheath and examined.The distal section of the sheath tubing was separated with exposed coil exiting the distal separation site.The coil was wrapped around the dilator shaft.A section of coil was separated.The distal section of separated tubing was not present.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Per the ifu, "warnings: before withdrawing the sheath through tortuous anatomy, insert the introducer dilator to avoid possible breakage.Precautions: this product is intended for use by physicians trained and experienced in diagnostic and interventional techniques.Standard techniques for placement of vascular access sheaths should be employed.Do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt.Sheath introduction: insert the dilator completely into the introducer.Using standard seldinger technique, access the target vessel with the appropriate needle.Insert wire into the vessel through the needle, then remove needle, leaving the wire guide in place.Insert dilator/sheath combination over wire guide.Remove wire guide and dilator, aspirate and flush introducer side-arm.Insert appropriately sized device as needed.Sheath removal: insert wire guide at least 10 centimeters (cm) past the tip of the sheath.Insert the dilator over the wire into the sheath.Withdraw the sheath and dilator as a unit.Remove the wire guide." based on the information provided, examination of the returned product, and the results of our investigation, the root cause of this event was determined to likely be related to patient condition as the tortuous/ calcified groin could have damaged the device and/ or caused the device to become stuck, leading to material separation during removal.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: FLEXOR RAABE GUIDING SHEATH
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7154998
• MDR Text Key: 96056538
• Report Number: 1820334-2017-04575
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002122666
• UDI-Public: (01)00827002122666(17)200731(10)8105920
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: KCFW-6.0-38-90-RB-RAABE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR