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

Catalog Number	KCFN-6.0-18-13-RA-HC
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number = k152044.(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
It was reported that after completion of a peripheral coronary intervention angioplasty, another manufacturer's six (6) fr catheter and wire guide were removed from the flexor radial access set sheath, and the valve was observed to be broken and leaking blood.According to the initial reporter, no portion of the device remained inside the patient, nor did the patient experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the dilator was not present in the returned sample.The device was tested for leakage, and it was noticed that seepage at the disk occurred.The proximal fitting was disassembled for further examination.The slit in the disc intersects with the center hole, but the slit does not appear run edge to edge.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 no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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: 7110807
• Report Number: 1820334-2017-04484
• Device Sequence Number: 86274
• Product Code: DYB
• UDI-Device Identifier: 00827002356030
• UDI-Public: (01)00827002356030(17)200814(10)8073655
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2018

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 Catalogue Number: KCFN-6.0-18-13-RA-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/11/2017
• Supplement Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 03/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1