MAUDE Adverse Event Report: COOK INC FLEXOR RADIAL ACCESS SET; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
During a pci via radial approach procedure, the haemostatic valve was leaking blood badly when the dilator was removed.The introducer was exchanged and the procedure continued with no harm to patient reported.
Additional Manufacturer Narrative
The 510k: k152044.Acronym only was provided on initial report.A review of the complaint history, drawings, device history record, documentation, trends, quality control, and visual inspection / functional testing of the returned device was conducted during the investigation.A used flexor radial access set sheath and dilator were returned for investigation.Biomatter was present on the check-flo assembly and within the connecting tube of the sheath.The sheath proximal fitting appeared to have a silicone disc, and not a blue valve.Therefore, the check-flo was disassembled (after performing the leak test) to better visualize the disc, which confirmed that the device was assembled with a silicone disc.A leak test was performed on the complaint device by occluding the sheath tubing with hemostats and injecting water through the connecting tube assembly using a syringe.Leakage was observed through the center of the disc.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There was one other reported complaint 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.
Event or Problem Description
During a percutaneous coronary intervention via radial approach procedure, the haemostatic valve was leaking blood badly when the dilator was removed.The introducer was exchanged and the procedure continued with no harm to patient reported.

• Brand Name: FLEXOR RADIAL ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6204927
• Report Number: 1820334-2016-01608
• Device Sequence Number: 10993297
• Product Code: DYB
• UDI-Device Identifier: 00827002356085
• UDI-Public: (01)00827002356085(17)170701(10)4905661
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: KCFN-6.0-18-13-RA-S-HC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/27/2016
• Supplement Report FDA Received Date: 06/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR