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

Catalog Number KCFW-8.0-38-70-RB-RAABE

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2018

Event Type  malfunction  

Manufacturer Narrative

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 Description

It was reported that during a thoraco-abdominal endovascular aneurysm repair, a flexor raabe guiding sheath separated at the hub.While removing the device through the brachial access site, the hub/valve separated from the sheath (refer to this report).A second flexor raabe guiding sheath from a different lot number was reported to separate at the hub during the same procedure (refer to report reference number 1820334-2018-03854).Fluoroscopy was used during the procedure and a wire guide was in the device at the time of the event.It was reported that the dilators were not inserted prior to removal.The patient's anatomy was reported to be tortuous without vessel calcification.Resistance was reported upon removal of the device; however was described as "not anything unusually difficult".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.The procedure was completed successfully with a "good outcome.".

Manufacturer Narrative

Investigation evaluation.Reviews of the dimensional verification, complaint history, device history record, documentation, drawing, instructions for use (ifu), manufactures instructions, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one kcfw-8.0-38-70-rb-raabe sheath was returned for investigation.There was a trace amount of biomatter inside the check-flo hub, however it was not clear whether the device was actually used or not.There was no notable damage on the sheath surface, however the sheath was confirmed to be separated from the proximal hub.The connector cap inner diameter was found to be within specifications.The flare was out of round, but still passed the flare gauge.It could not be confirmed whether the flare was manufactured out of specification due to the potential damage during use or separation.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.Furthermore, reviews of the manufactures instructions, drawings, quality control procedures, and overall design history file were conducted, and no gaps were discovered.Moreover, an ifu is provided with the device, which states ¿before withdrawing the sheath through tortuous anatomy, insert the introducer dilator to avoid possible breakage." then goes on to say ¿insert the introducer dilator over the wire into the sheath.3.Withdraw the sheath and dilator as a unit." based on the information provided and the examination of the returned product, investigation has concluded that this event was caused by unintended use error as the dilator was not reinserted prior to removal as instructions indicate.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 Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.This mdr is being submitted as having information not previously reported.Additional complaint investigation and record remediation was not performed.Corrected information: g5: 510(k)= k142829.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.

• Brand Name: FLEXOR RAABE GUIDING SHEATH
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8206131
• MDR Text Key: 131722961
• Report Number: 1820334-2018-03853
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2021
• Device Catalogue Number: KCFW-8.0-38-70-RB-RAABE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Date Manufacturer Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN MANUFACTURER'S WIRE AND CATHETER.; UNKNOWN MANUFACTURER'S WIRE AND CATHETER