MAUDE Adverse Event Report: COOK INC PERFORMER MULLINS GUIDING SHEATH; DYB INTRODUCER, CATHETER

Model Number	G09380
Health Effect - Clinical Code	Chemical Exposure (2570)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
It was reported during the patient's angiogram procedure, while preparing to perform a run, contrast sprayed back (from back end) at the users.This occurred twice.The customer indicated that at both occurrences another manufacturer's balloon was in the sheath.It was also noted that during the procedure another manufacturer's laser was used.The facility was able to complete the procedure with the complaint device.Additional information provided identified the device was in the patient at the time of the incident.

• Brand Name: PERFORMER MULLINS GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6931646
• Report Number: 1820334-2017-03374
• Device Sequence Number: 1208458
• Product Code: DYB
• UDI-Device Identifier: 00827002093805
• UDI-Public: (01)00827002093805(17)171125(10)5474690
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/09/2017

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: G09380
• Device Catalogue Number: RCFW-6.0-38-48-RB-MTS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 10/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1