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

Catalog Number KCFW-6.0-38-55-RB-RAABE

Device Problems Material Separation (1562); Unraveled Material (1664)

Patient Problems Death (1802); No Code Available (3191)

Event Date 08/23/2019

Event Type  Death  

Manufacturer Narrative

Occupation: unknown.(b)(4).Pma/510(k) number: re-amendment (raabe sheath).A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported, during an angiogram, an unknown cook raabe sheath unraveled.Reportedly, a section of the device separated and required surgical removal.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information regarding event details, patient anatomy and outcome has been requested, but is not available at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.D11: concomitant products= powerflex 6mm pta balloon, advantage.035 260cm wire guide e1: customer name and address= (b)(6).Investigation - evaluation.Reviews of the complaint history, instructions for use (ifu), drawings, manufacturer¿s instructions, quality control procedures, and specifications were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.The device is shipped with instruction for use (ifu) which states that reinsertion of the dilator prior to removal of the sheath ¿increases the strength of the sheath and lessens the risk of device separation¿ and also suggests inserting the dilator prior to removal if resistance is encountered or anticipated during withdrawal of the device.Reportedly, the treating physician noted the sheath began to stretch during removal, and then he tried to reinsert the dilator.Based on the information provided and no product returned, investigation has concluded that this event could not be traced to the device, but to the patient¿s condition and unintended use error.Again, the dilator was not reinserted prior to the removal attempt but after stretching of the device had already occurred.Additionally, the patient¿s outcome was reported as ¿good¿, and the patient was reportedly discharged and ¿doing well¿ at a post-op follow-up visit on day eight (post-op).The patient died nine days after the procedure of unknown causes.It is unknown if this event was related in any way to the patient¿s death.Attempts to gain additional information were unsuccessful.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

Additional information was received 27sep2019.Another manufacturer's pta balloon and wire guide were used during the procedure, which was performed on (b)(6) 2019.Heparin and heparinized saline were given during the procedure.The patient had a history of a previous right groin cut-down procedure and endarterectomy.Access was obtained in the right common femoral artery via a scarred groin for treatment of the left superficial femoral artery.The device was in place for 30-40 minutes and separated upon removal of the device.During removal, undue tension was reported and the sheath elongated.Slow traction was applied, the device was flushed with saline, and the dilator was reinserted; however, the sheath would not dislodge.The dilator and sheath were not removed as a unit.A guide wire was in the lumen of the device at the time of the event.An open cut-down of the external iliac artery was performed to remove the separated portion of the sheath.On (b)(6) 2019, information was received stating that the patient died on (b)(6) 2019.Limited product information was also received.On (b)(6) 2019, additional information was received from the treating physician.There is no identified cause of death and an autopsy report is not available.The initial procedure was angioplasty of the left superficial femoral and popliteal arteries, left anterior tibial artery, and left tibioperoneal trunk.The anatomy was reportedly scarred and resistance was reported upon insertion of the device; however, "no more than expected in a scarred groin".The patient reportedly had extensive peripheral vascular disease.The device reportedly stretched and the physician inserted the dilator to aid removal; although the dilator was not able to advance all the way to the tip of the sheath, reportedly because the sheath was "up and over" and the physician lost the ability to push.The device separated as it was removed.The procedure was considered to be successfully completed, the patient was discharged from the hospital after the initial procedure, and was seen for follow-up and "doing well" on post-op-day eight.On (b)(6)2019, information was received confirming that the device is currently with the user facility's risk management department and will not be returned.There has been no allegation that the patient's death was related in any way to the reported event.

Event Description

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

Manufacturer Narrative

This mdr is being submitted as having information not previously reported.Additional complaint investigation and record remediation was not performed.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 RAABE GUIDING SHEATH
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8959452
• MDR Text Key: 156408031
• Report Number: 1820334-2019-02204
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K142829
• 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: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: KCFW-6.0-38-55-RB-RAABE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 76 YR