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

Model Number G11638

Device Problem Material Separation (1562)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 07/02/2019

Event Type  Injury  

Manufacturer Narrative

Occupation.Unknown.Pma/510(k) number.Pre-amendment.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during a procedure involving a peripheral runoff of the right leg, the tip of a flexor raabe guiding sheath separated upon removal of the device, exposing the coil of the sheath.The (b)(6) year old male patient's anatomy was reportedly calcified and scarred from previous procedures.Access was obtained in the left femoral artery and the device was advanced up and over the bifurcation.The sheath was reportedly in place for 28 minutes.An unknown 6 french guide catheter and unknown wire were used during the procedure, and heparin was given to the patient ten minutes prior to attempted removal of the device.Resistance was reported upon removal.The dilator was not inserted into the device prior to removal; however a wire and catheter were in the lumen of the device when the separation occurred.The exposed coil became dislodged and elongated and the tip of the device remained lodged in the patient's artery.Attempted retrieval using a snare was unsuccessful; therefore a stent was used to "jail" the separated portion of the device to the artery.The procedure was not completed and the patient was admitted to the hospital for observation.

Event Description

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

Manufacturer Narrative

Investigation/evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturer¿s instructions, and quality control procedures of the device 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.A review of the 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.Furthermore, reviews of the manufacturer¿s instructions, drawing, and quality control procedures were conducted, and no gaps were discovered.The device is packaged with instructions for use (ifu), which state that if resistance is encountered during sheath advancement, ¿assess cause of resistance and consider dilation of any restriction identified or consider alternate treatment strategy.If flexor sheath is advanced through resistance, force to remove the sheath will be higher, increasing the risk of sheath material or hub separation upon withdrawal.¿ the ifu also 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 suggests insertion of the dilator prior to removal if resistance is encountered or anticipated during withdrawal of the device.The user reportedly did not reinsert the dilator prior to device removal.Based on the information provided and no product returned, investigation has concluded that the device failure cannot be traced to the device, but rather may be traced to the user and unintended use error as well as the patient condition.The patient's anatomy was reportedly scarred and calcified.Resistance was reported; however, the dilator was not reinserted prior to removing the device.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.

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.

Event Description

No new patient or event information since the last report was submitted.

• 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: 8772740
• MDR Text Key: 150453574
• Report Number: 1820334-2019-01645
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002116382
• UDI-Public: (01)00827002116382(17)220405(10)9647146
• 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,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2022
• Device Model Number: G11638
• Device Catalogue Number: KCFW-6.0-38-55-RB-RAABE
• Device Lot Number: 9647146
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/02/2019
• Initial Date FDA Received: 07/09/2019
• Supplement Dates Manufacturer Received: 09/09/2019; 04/06/2020
• Supplement Dates FDA Received: 09/10/2019; 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR