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

Model Number	G49046
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.It is unknown if the device will be returned.(b)(6).Pma/510(k) number = k142829.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 unknown procedure, the coating was coming off of a flexor high-flex ansel guiding sheath.Additional information regarding event details, patient anatomy and outcome has been requested, but is not available at this time.
Additional Manufacturer Narrative
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 or Problem Description
Additional information received 28feb2020.As reported, the device was activated by dipping into saline solution prior to use.The device was then inserted via right femoral access for placement of an aortic stent graft.Coating detachment was observed one minute following insertion of the device.The device was then immediately removed and replaced.Powdered gloves were used.Vessel spasms were not reported.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during an unknown procedure, the coating was coming off of a flexor high-flex ansel guiding sheath.Additional information received 28feb2020.As reported, the device was activated by dipping into saline solution prior to use.The device was then inserted via right femoral access for placement of an aortic stent graft.Coating detachment was observed one-minute following insertion of the device.The device was then immediately removed and replaced.Powdered gloves were used.Vessel spasms were not reported.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, personnel interview, and quality control procedures was conducted during the investigation, as well as a visual inspection of the complaint device.The complaint device was returned with bio-matter present, the dilator fully inserted into the sheath, and approximately four centimeters of the tnrt liner exiting the sheath.When removed, the section of separated tnrt liner was measured to be approximately 33.3 centimeters long.A document-based investigation evaluation was performed.A review of the device history record revealed no related nonconformances associated with this lot.A complaint history search revealed no other complaints associated with this lot number.As 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 additional nonconforming product exists in house or in the field.The product ifu states ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ it was confirmed from the device failure analysis and manufacturing documents that the device was manufactured out of specification.There is not, however, sufficient evidence to suggest that there are additional nonconforming devices from the complaint lot in house or in the field.Investigation has concluded that this event can be traced to a quality control deficiency.The delamination found on the complaint sheath is consistent with a previously conducted nonconformance investigation.The nonconformance investigation determined that the failure is related to inadequate quality control measures.The complaint device was manufactured prior to implementation of actions put in place resulting from that investigation.In addition, there is currently an open capa investigation regarding this failure.The risk assessment for this failure mode was reviewed and no additional escalation actions are required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 9757038
• Report Number: 1820334-2020-00469
• Device Sequence Number: 2787216
• Product Code: DYB
• UDI-Device Identifier: 00827002490468
• UDI-Public: (01)00827002490468(17)220528(10)9767673
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2020

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: 05/28/2022
• Device Model Number: G49046
• Device Catalogue Number: KCFW-8.0-35-110-RB-HFANL1-HC
• Device Lot Number: 9767673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 02/28/2020; 04/09/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 03/02/2020; 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1