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

Model Number	G47701
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seizures (2063)
Date of Event	02/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Inital reporter occupation = unknown.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, a female patient with a history of a thoracoabdominal aneurysm had seizures after a procedure involving placement of two unknown stent grafts within the descending thoracic aorta, a custom-made branch, and a fenestrated graft.The procedure was reportedly uneventful and completed in "satisfactory" time.Initially, a cook representative was told that the patient suffered a posterior circulation stroke after the procedure.One of the surgeons involved in the procedure stated that the cook flexor high-flex ansel guiding sheath, which was inserted via the axillary artery into the left subclavian artery, had potentially occluded blood flow to the brain due to the patient's small size.Additional information was received 25feb2020, however, stating the patient did not have a stroke, but did have seizures after surgery, which had since resolved.The patient is recovering well.Per the user facility, no additional information will be available.There has been no alleged malfunction of the cook device.
Event or Problem Description
No new patient or event information to report.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: as reported, a female patient with a history of a thoracoabdominal aneurysm had seizures after a procedure involving placement of two unknown stent grafts within the descending thoracic aorta, a custom-made branch, and a fenestrated graft.The procedure was reportedly uneventful and completed in "satisfactory" time.Initially, a cook representative was told that the patient suffered a posterior circulation stroke after the procedure.One of the surgeons involved in the procedure stated that the cook flexor high-flex ansel guiding sheath, which was inserted via the axillary artery into the left subclavian artery, had potentially occluded blood flow to the brain due to the patient's small size.Additional information was received 25feb2020, however, stating the patient did not have a stroke, but did have seizures after surgery, which had since resolved.The patient is recovering well.Per the user facility, no additional information will be available.There has been no alleged malfunction of the cook device.Investigation ¿ evaluation a document based investigation was performed including a review of complaint history, device history record, and,quality control data.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.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.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 event description and the investigation there was objective evidence that the device was manufactured to specification.There has been no reported malfunction of the cook device.With current limited information, causes for this event may be traced to patient condition or procedural/user issues.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 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: 9782030
• Report Number: 1820334-2020-00538
• Device Sequence Number: 16283528
• Product Code: DYB
• UDI-Device Identifier: 00827002477018
• UDI-Public: (01)00827002477018(17)211120(10)9324993
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/20/2021
• Device Model Number: G47701
• Device Catalogue Number: KCFW-12.0-35-45-RB-HFANL1-HC
• Device Lot Number: 9324993
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 45