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

Model Number	G56223
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: non-healthcare professional.Pma/510(k) number: pre-amendment.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 endovascular aneurysm repair involving a patient of unknown age and gender, a flexor high-flex ansel guiding sheath separated at the hub during removal of the device through another manufacturer's 12 french sheath.Access was obtained in the axillary artery and the anatomy was reported to be tortuous.The sheath was in place for five to ten minutes.It is unknown if resistance was encountered during the procedure.The dilator was reinserted prior to removal and the hub separated with the dilator and another manufacturer's wire guide in place.Blood loss was reported as minimal and no intervention was needed.The device, including the dilator, was removed by hand and the patient's outcome was reported as "good".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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation reviews of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, specifications, and quality control procedures and a visual inspection of the returned device were conducted during the investigation.One device was returned for investigation.The returned packaging confirms the reported complaint device lot number.The visual inspection of the returned device confirmed separation of the hub from the device.No shaft material separation was noted.The flare of the sheath was intact, with slight damage noted.No damage was observed to the connector cap.The flare and connector cap measured within specification.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 a single nonconforming event which could contribute to this failure mode.The non-conforming unit was identified and scrapped prior to packaging.It should be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturing instructions, specifications, drawings and quality control procedures were conducted, and no gaps were discovered.The device is packaged with instructions for use, which warn, ¿if resistance in encountered during advancement of the flexor sheath, asses 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 material or hub separation upon withdrawal.¿ based on the information provided and the examination of the returned product, investigation has concluded that the device failure can be attributed to the patient¿s reportedly tortuous anatomy.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 or Problem Description
No new patient or event information to report.
Additional Manufacturer Narrative
This mdr is being submitted as having information not previously reported.Additional complaint investigation and record remediation was not performed.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: 8816521
• Report Number: 1820334-2019-01763
• Device Sequence Number: 321000
• Product Code: DYB
• UDI-Device Identifier: 00827002562233
• UDI-Public: (01)00827002562233(17)220523(10)9761538
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 04/09/2020

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: 05/23/2022
• Device Model Number: G56223
• Device Catalogue Number: KCFW-8.0-35-70-RB-HFANL0-HC
• Device Lot Number: 9761538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 11/04/2019; 04/09/2020
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 11/05/2019; 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 12 FR GORE DRYSEAL SHEATH, BOSTON V18 WIRE; 12 FR GORE DRYSEAL SHEATH, BOSTON V18 WIRE