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

Model Number N/A

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

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

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

Customer name and address: phone: (b)(6).(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 an unspecified below-the-knee procedure via contralateral access, a flexor ansel guiding sheath unraveled and separated at the tip upon removal of the device.The user reported tension and difficulty removing the sheath from the patient.Upon removal, the device began to unravel, with the coils elongating and coming out from the patient as a fine, curly wire.The sheath then separated, leaving a portion of the distal tip inside the patient.The separated portion of the device was stented in place to isolate the tip from the vessel lumen.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information has been requested, but is currently unavailable.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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.

Event Description

Additional information was received 11dec2020.Access was reportedly obtained in the superficial femoral artery and the access site was scarred.The patient had a history of an open femoral bypass procedure and the anatomy was tortuous, calcified, and scarred.The sheath was in place for one hour.Another manufacturer¿s 0.035-inch wire guide was in the lumen of the device at the time of separation.Resistance was not encountered on insertion; however, resistance was reported upon removal of the device.The dilator was not reinserted prior to removal and was not in place at the time of separation.The hub was used to pull the sheath from the patient.The patient is reportedly fine.

Manufacturer Narrative

Description of event: as reported, during an unspecified below-the-knee procedure via contralateral access, a flexor ansel guiding sheath unraveled and separated at the tip upon removal of the device.Access was reportedly obtained in the superficial femoral artery and the access site was scarred.The user reported tension and difficulty removing the sheath from the patient after it had been in place for an hour.Upon removal, the device began to unravel, with the coils elongating and coming out from the patient as a fine, curly wire.The sheath then separated, leaving a portion of the distal tip inside the patient.The separated portion of the device was stented in place to isolate the tip from the vessel lumen.Another manufacturer¿s 0.035-inch wire guide was in the lumen of the device at the time of separation.The patient had a history of an open femoral bypass procedure and the anatomy was tortuous, calcified, and scarred.Investigation ¿ evaluation a document based investigation was performed including a review of complaint history, documentation, drawings, the instructions for use, manufacturing instructions, quality control data, and specifications.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 made out of specification.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: -the intended use for this device is ¿to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.¿ -choose a sheath size large enough to accommodate the maximum outer diameter of any device used through the sheath, to ensure compatibility of the devices.-that all interventional or diagnostic instruments should move freely through the valve and sheath to avoid damage.- 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¿.-regarding removal, the ifu instructs the user to insert a wire guide until the wire tip extends at least 10cm past the tip of the sheath.-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.A capa was previously initiated regarding this failure mode.The capa team did not arrive at a definitive root cause and was closed at the end of the root cause phase.The following primary contributing factors have been identified: a.) these devices can be advanced into restrictive anatomies.The capa investigation showed that clinical users may be using these devices to force through restrictive anatomy, causing separation upon removal.B.) instructions for use warn to reinsert the dilator prior to removal.Investigation has identified that this is not always performed.No corrective actions will be pursued as the root cause investigation has identified that the product conforms to all design requirements and the incident rate is within the identified acceptable risk level.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook could not determine the cause of failure.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.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 to report.

• Brand Name: FLEXOR ANSEL GUIDING SHEATH
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10938141
• MDR Text Key: 219315295
• Report Number: 1820334-2020-02226
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: KCFW-6.0-18/38-45-RB-ANL1-HC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARMADA BALLOON; SUPERA STENT; TERUMO GUIDE WIRE; ARMADA BALLOON; SUPERA STENT; TERUMO GUIDE WIRE
• Patient Outcome(s): Other; Required Intervention