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

Model Number	G10675
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer name and address= no information provided.Occupation = no information provided.Pma/510(k) number = pre-amendment.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As found on the maude database, during angioplasty of a right "atrioventricular" fistula, the tip of a performer introducer separated.The sheath was not intact upon removal of the device and the tip of the sheath was reportedly visualized under fluoroscopy.Pressure was held by a physician to prevent the sheath from moving and to prevent bleeding.Further details of the event are unknown, and customer information was not provided.
Additional Manufacturer Narrative
Investigation - evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control procedures, and specifications of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was conducted.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturing instructions, drawing, specifications, and quality control procedures were conducted, and no gaps were discovered.The device is packaged with instructions for use, which warn, ¿before withdrawing the sheath through tortuous anatomy, insert the introducer dilator to avoid breakage." based on the information provided and no product returned, investigation has concluded that a cause for the device failure could not be determined.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9146005
• Report Number: 1820334-2019-02512
• Device Sequence Number: 19497343
• Product Code: DYB
• UDI-Device Identifier: 00827002106758
• UDI-Public: (01)00827002106758(17)191117(10)7453823
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2020

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: 11/17/2019
• Device Model Number: G10675
• Device Catalogue Number: RYCFW-6.0-35-6-RB-CW
• Device Lot Number: 7453823
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 01/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1