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

Model Number	G56231
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: lab manager.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during an unspecified procedure of the superficial femoral artery, via common femoral access, a flexor high-flex ansel guiding sheath unraveled and separated.The sheath and dilator were inserted over a cook amplatz wire guide.Resistance was encountered, and the device stopped advancing at approximately four centimeters into the body.The user decided to pull the sheath out, with the dilator in place.Resistance was encountered upon removal, and the sheath subsequently uncoiled and the tip separated.The tip was inside the body; however, the rest of the separated portion was sticking out of the skin.Hemostats were used to pull the separated portion from the patient.Nothing remained in the body, and another manufacturer¿s sheath was used to complete the procedure.The anatomy was not calcified, tortuous, or scarred.The sheath was in place for one to two minutes.No portion of the device was left inside the patient.This did not result in the need for additional procedures or prolonged hospitalization.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Description of event: as reported, during an unspecified procedure of the superficial femoral artery, via common femoral access, a flexor high-flex ansel guiding sheath unraveled and separated.The sheath and dilator were inserted over a cook amplatz wire guide.Resistance was encountered, and the device stopped advancing at approximately four centimeters into the body.The user decided to pull the sheath out, with the dilator in place.Resistance was encountered upon removal, and the sheath subsequently uncoiled and the tip separated.The tip was inside the body; however, the rest of the separated portion was sticking out of the skin.Hemostats were used to pull the separated portion from the patient.Nothing remained in the body, and another manufacturer¿s sheath was used to complete the procedure.The anatomy was not calcified, tortuous, or scarred.The sheath was in place for one to two minutes.Investigation ¿ evaluation a visual inspection, dimensional verification, and functional testing 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, interview of personnel, manufacturing instructions, quality control data, and specifications.The complainant returned one kcfw-6.0-35-55-rb-hfanl0-hc used to cook for investigation.Physical examination of the returned device showed: one used 6fr sheath received with the dilator inserted.There was one section of total sheath separation measured 6.5cm.Another section of material separation measured 3cm.Coil elongation is present.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 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.Instructions for use sheath introduction 1.If the device has hydrophilic coating, activate the coating by wetting the outer surface of the device with heparinized saline.Note: for best results, maintain wetted condition of device during placement.How supplied upon removal from package, inspect the product to ensure no damage has occurred.A capa was opened and is actually ongoing for this issue.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 bond separation 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.
Event or Problem Description
No new patient or event information to report.

• Brand Name: FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10804620
• Report Number: 1820334-2020-02035
• Device Sequence Number: 1138481
• Product Code: DYB
• UDI-Device Identifier: 00827002562318
• UDI-Public: (01)00827002562318(17)230805(10)13349035
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/05/2023
• Device Model Number: G56231
• Device Catalogue Number: KCFW-6.0-35-55-RB-HFANL0-HC
• Device Lot Number: 13349035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 03/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1