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

Model Number G44154

Device Problem Material Separation (1562)

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

Event Date 05/09/2019

Event Type  Injury  

Manufacturer Narrative

Occupation: non-healthcare professional.Pma/510(k) number = pre-amendment.(b)(4).This report includes information known at this time.A follow-up report will be submitted at the conclusion of the investigation or, when additional relevant information becomes available.

Event Description

It was reported, a patient (demographics and medical history unknown) was undergoing angioplasty of the superficial femoral artery via access in the left groin; target lesion was in the right external iliac.Anatomy was scarred and calcified.Upon removal of a flexor ansel guiding sheath, it broke and the tip was retained in the patient's anatomy.The complaint device is estimated to have been in place approximately thirty minutes and there was resistance upon insertion and removal.A wire guide was also in use and the manufacturer is not known.I was also reported that the complaint sheath and dilator were not withdrawn together.Retrieval of the detached portion of the device was attempted but was unsuccessful.There are no further plans to retrieve it.It is unknown how much of the complaint device remain in the patient's anatomy.After the procedure, the patient was discharged in stable conditional.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation reviews of the dimensional verification, complaint history, device history record, instructions for use (ifu), manufacturer¿s instructions, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one separated kcfw-6.0-18/38-45-rb-anl0-hc without the dilator was returned for investigation.There was extensive biomatter throughout the separated segments.The entire length of the sheath was severely accordion and unraveled.The first segment of tubing measured 13.5cm from the proximal hub.Attached to this segment was 19.6cm of exposed coiling with sections of inner liner attached.This coiling was also connected to a 19.0cm section of sheath tubing (segment 2).Segment 2 also contains another 10cm of exposed coiling exiting the distal end.This coiling also had sections of inner liner attached.The coiling connects to the third segment of tubing measured 9.7cm.The third segment did not have coiling exiting the distal end of segment 3.There was however a separated section of coiling which measured approximately 34cm.This coiling also had inner liner attached.The radiopaque marker band was not present on the device and was not returned.Due to the extensive damage, it is unknown how much of the device remained in the patient.Additionally, 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 showed no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, drawings, specifications, and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with the device, which states ¿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.Based on the information provided and the examination of the returned product, investigation has concluded that this event cannot be traced to the device but instead to the patient condition and unintended user error.Reportedly, the patient had heavily calcified anatomy and the user did not reinsert the dilator prior to the removal attempt per ifu recommendation.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 on (b)(6) 2019 clarifying that the physician opted against an additional intervention because they believed the location of the separated piece did not pose a risk to the patient.However, they will continue to monitor it.

Event Description

No new patient or event information to report.

Manufacturer Narrative

This mdr is being submitted as having information not previously reported.Additional complaint investigation and record remediation was not performed.Blank fields on this form indicate the information is unknown or unavailable.Correction: g5.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 ANSEL GUIDING SHEATH
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8616159
• MDR Text Key: 145255723
• Report Number: 1820334-2019-01203
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002441545
• UDI-Public: (01)00827002441545(17)211213(10)9379267
• 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: 04/08/2020

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: 12/13/2021
• Device Model Number: G44154
• Device Catalogue Number: KCFW-6.0-18/38-45-RB-ANL0-HC
• Device Lot Number: 9379267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Initial Date Manufacturer Received: 05/09/2019
• Initial Date FDA Received: 05/16/2019
• Supplement Dates Manufacturer Received: 06/06/2019; 04/08/2020
• Supplement Dates FDA Received: 06/19/2019; 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention