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

Model Number	G08550
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number = pre-amendment.(b)(4).Investigation - evaluation: a review of the complaint history and device history record review was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.However, a document-based investigation was performed.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 could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Based on the information provided, no product returned, and the results of our investigation, a definitive root cause could not be determined.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
It was reported, the tip of the performer introducer was noted to be damaged when it was removed from it's packaging.The damage was described as a rough end with sharp edges.The device was not used during the unspecified procedure.Another performer introducer was used to complete the procedure.No adverse effects have been reported.Reportedly, the complaint device is available for return to the manufacturer; however, it has not been received to date.A follow up report will be submitted should it be received for investigation.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7695700
• Report Number: 1820334-2018-02207
• Device Sequence Number: 1108276
• Product Code: DYB
• UDI-Device Identifier: 00827002085503
• UDI-Public: (01)00827002085503(17)210316(10)8661169
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/17/2018

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 Expiration Date: 03/16/2021
• Device Model Number: G08550
• Device Catalogue Number: RCFW-6.0-38-30-RB
• Device Lot Number: 8661169
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 07/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1