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

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	05/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information and/or completion of the investigation.
Event or Problem Description
It was reported that during a thoraco-abdominal aneurysm repair, a t-branch graft implant was placed with a 12f high-flex ansel guiding sheath introducer via high brachial cut down.The 12f sheath valve was leaking / squirting with each heartbeat (manufacturers report number 1820334-2017-01351) while a competitor's 4f catheter was placed over a wire through the valve.The sheath was replaced with a second 12f flexor high-flex ansel guiding sheath, which also had some leakage, but eventually stopped (manufacturers report number 1820334-2017-01368).The patient did not require any additional procedures due to this occurrence.The doctor approximated 500 cc of blood loss.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications,quality control, visual inspection, and functional testing of the returned device was conducted during the investigation.The flexor high-flex ansel guiding sheath was returned with the dilator inserted.No visible damage was noted.The dilator was removed and the sheath was tested for leakage by occluding the sheath tubing with hemostats and injected with water.Leakage was detected at the check-flo valve.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the information provided, examination of the returned product, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• 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: 6661081
• Report Number: 1820334-2017-01351
• Device Sequence Number: 19216907
• Product Code: DYB
• UDI-Device Identifier: 00827002477018
• UDI-Public: (01)00827002477018(17)191219(10)7530038X
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: KCFW-12.0-35-45-RB-HFANL1-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/23/2017
• Supplement Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 06/22/2017
• Supplement Report FDA Received Date: 09/18/2017
• 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 Age: 57 DA