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

Model Number	G08024
Medical Device Problem Code	Split (2537)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
It was reported that prior to use upon opening, the plastic end of the performer introducer was noted to be split.The introducer did not come into contact with a patient as it was not used.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, drawings, manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.The performer introducer and its components (10 fr dilator, 12 fr dilator, 14 fr dilator and a 0.038 inch diameter wire guide) were returned.A 1.3 centimeter (cm) lengthwise crack was noted on the connector cap.The crack penetrates through the hub.The 14 fr dilator was inserted into the introducer.The transition between the introducer and the dilator was smooth.The inner diameter of the connector cap was measured and lies within the specified limits indicating that the correct connector cap was used to build the device.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements.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, the root cause of this event was determined to be related to package handling during shipping, manipulation of the package, or storage.Per the quality engineering risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7064198
• Report Number: 1820334-2017-04012
• Device Sequence Number: 1379229
• Product Code: DYB
• UDI-Device Identifier: 00827002080249
• UDI-Public: (01)00827002080249(17)200919(10)8204989
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2018

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: G08024
• Device Catalogue Number: RCF-14.0-38-J
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/10/2017
• Supplement Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 11/28/2017
• Supplement Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1