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

Model Number	G07919
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number = pre-amendment.Investigation - evaluation a review of the complaint history, device history record, manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.The rsrcf-6.5-13-rb sheath of the rcfw-6.0-35-rb set was returned with the jcd6.0-35-20-ol dilator fully inserted through the proximal fitting in a prepped condition.Two 1 mm compressions are present on distal tip.The distal end hole is partially obstructed due to the compressions.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, examination of the returned product, and the results of our investigation, a definite root cause could not be determined.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 that the grey tip of the rcfw-6.0-35-rb performer introducer was damaged prior to removal from the package.It was not used.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information regarding patient anatomy and outcome has been requested, but is not available at this time.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7425637
• Report Number: 1820334-2018-00906
• Device Sequence Number: 1717080
• Product Code: DYB
• UDI-Device Identifier: 00827002079199
• UDI-Public: (01)00827002079199(17)200809(10)8073684
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/12/2018

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 Model Number: G07919
• Device Catalogue Number: RCFW-6.0-35-RB
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1