MAUDE Adverse Event Report: COOK INC PERFORMER INTRODUCER; 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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported the performer introducer valve was leaking during the procedure.The device was exchanged during the procedure.The patient had no adverse consequence due to this event.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, manufacturing instructions and quality control of the returned device was conducted during the investigation.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.No images were available and a review of the product was not performed as the device was not returned for evaluation.The device history record was reviewed and no non-conformances were noted.A search revealed this complaint to be the only reported complaint associated to the complaint lot number 6968919.Although the devices were not returned for evaluation, the root cause was determined to be manufacturing related.Measures have been previously initiated to address this issue.A quality engineering risk assessment has determined that no further action is required as it concluded that its occurrence is unlikely to lead to a serious health consequence to the patient.We will continue to monitor for similar complaints.
Event or Problem Description
It was reported the performer introducer valve was leaking during the procedure.The device was exchanged during the procedure.The patient had no adverse consequence due to this event.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6151023
• Report Number: 1820334-2016-01431
• Device Sequence Number: 16374128
• Product Code: DYB
• UDI-Device Identifier: 00827002134959
• UDI-Public: (01)00827002134959(17)190512(10)6968919
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2016

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: RYCFW-6.0-35-6-CW
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/07/2016
• Supplement Report FDA Received Date: 01/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1