MAUDE Adverse Event Report: COOK INC FLEXOR RAABE 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	03/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
During a procedure to exclude a thoracic abdominal aneurysm on the (b)(6) female patient, the introducer valve began to leak.As the room was dark during the procedure, the leakage was not noted until the patient's blood loss began to drip onto the floor.As the patient blood loss equaled approx.1 liter, a transfusion was given at this point.The introducer has been exchanged.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Date of birth reported as (b)(6).A review of the complaint history, device history record, instructions for use (ifu), trends, quality control, and visual inspection / functional testing of the returned device was conducted during the investigation.A flexor raabe guiding sheath (sheath and dilator) were returned for investigation.No damage was noted to the sheath tubing or dilator tubing.Upon visual inspection of the silicone disc, biomatter and an opaque substance were found.It is possible that the opaque substance is dried contrast agent.After flushing the sheath, a leak test was performed by occluding the sheath tubing with hemostats and injecting water through the connecting tube assembly using a syringe.No leakage occurred.The dilator was fully inserted into the sheath and then removed.Another leak test was performed.Leakage was detected through the center of the silicone disc.It was reported that several 5f catheters and 0.035 wires had been utilized through the sheath; exchanging devices several times through the sheath may have affected the silicone disc's ability to maintain hemostasis.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 and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• Brand Name: FLEXOR RAABE GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6394948
• Report Number: 1820334-2017-00510
• Device Sequence Number: 673293
• Product Code: DYB
• UDI-Device Identifier: 00827002126060
• UDI-Public: (01)00827002126060(17)190921(10)7292027
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2017

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-9.0-38-70-RB-RAABE
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/02/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/02/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2017
• Supplement Report FDA Received Date: 06/28/2017
• 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: Required Intervention
• Patient Age: 48 YR