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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.Five performer introducers were returned for evaluation.All five dilators had surface defects on the taper that occurred in an area approximately 4-6 millimeters (mm) from the distal tip.A dark discoloration was also present on all five dilator tapers.A document-based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.There were no other reported complaints for this lot number.Based on the information provided and results of the investigation, a definitive root cause could not conclusively be determined.Per the risk assessment, no further action is required.We will continue to monitor for similar complaints.
Event or Problem Description
An international customer reported that the tip of the performer introducer dilator was deformed.The malfunction was discovered prior to patient contact.No further information was provided.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 6740123
• Report Number: 1820334-2017-02069
• Device Sequence Number: 1267680
• Product Code: DYB
• UDI-Device Identifier: 00827002086586
• UDI-Public: (01)00827002086586(17)190830(10)NS7201456
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2017

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: RCFW-7.0-38-80-RB
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2017
• Initial Report FDA Received Date: 07/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1