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

Model Number G29985

Device Problem Detachment of Device or Device Component (2907)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation: manager, process transformation and quality.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 an angiogram, angioplasty, and stent placement, the hub separated from a flexor ansel guiding sheath.Although the initial complaint stated that the "tip came apart", a photo provided by the user facility shows hub separation instead of sheath separation.The device had been in place for thirty minutes at the time of the event.Bleeding was reported; although, it is unknown at this time if any intervention was required for blood loss.Additional information has been requested, but is unavailable at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.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 provided on 27jan2021: no unintended section of the device remained inside of the patient's body.No additional procedures were required due to this occurrence.There as no surgical or medical intervention required due to this occurrence.No adverse effects to the patient were reported due to this occurrence.There is no patient information available.

Event Description

No new patient or event information to report.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: as reported, during a procedure involving an angiogram, angioplasty, and stent placement, the hub separated from a flexor ansel guiding sheath.Although the initial complaint stated that the "tip came apart", a photo provided by the user facility shows hub separation instead of sheath separation.The device had been in place for thirty minutes at the time of the event.Bleeding was reported.No unintended section of the device remained inside of the patient's body.No additional procedures were required due to this occurrence.There as no surgical or medical intervention required due to this occurrence.No adverse effects to the patient were reported due to this occurrence.Investigation ¿ evaluation a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, documentation, drawings, the instructions for use, manufacturing instructions, quality control data, and specifications.The complainant returned one used flexor ansel guiding sheath for investigation.Physical examination of the returned device showed: the hub was separated.Flare was in tact.There were hemostat marks between 0.5cm and 2.2cm from the distal end of the flare.There was no other damage to the sheath.The distal tip was intact.The connector cap measured within specifications.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in the field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: warnings if resistance is encountered during advancement of flexor sheath, 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.Reinsertion of dilator prior to removal of flexor sheath increases the strength of the sheath and lessens the risk of device separation.If resistance is anticipated or encountered during withdrawal of flexor sheath, consider carefully reinserting the dilator prior to continuing removal.Precautions in order to ensure device compatibility, choose a sheath size large enough to accommodate the maximum outer diameter of any devices that will be placed through the sheath.All interventional or diagnostic instruments used with this product should move freely through the valve and sheath to avoid damage.Instructions for use sheath introduction 1.Ensure that the inner diameter (id) of the sheath is appropriate for the maximum diameter of the instruments to be introduced.2.Using the side-arm of the valve, flush the sheath by filling the sheath assembly completely with heparinized saline.3.Flush the dilator with heparinized saline.How supplied upon removal from package, inspect the product to ensure no damage has occurred.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.Based on the provided evidence and the completed investigation, cook has concluded component failure contributed to this incident.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.

• 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: 11035999
• MDR Text Key: 222396830
• Report Number: 1820334-2020-02335
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002299856
• UDI-Public: (01)00827002299856(17)230123(10)10285385
• 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: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2023
• Device Model Number: G29985
• Device Catalogue Number: KCFW-7.0-18/38-45-RB-ANL1-HC
• Device Lot Number: 10285385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2020
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1