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

Model Number	G08957
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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
It was reported that during an endovascular aneurysm repair (evar), the dilator of the performer introducer came out as it was introduced into the patient's anatomy.This caused a leakage of blood.A portion of the device remained in place to keep access, and a new introducer was used to successfully complete the procedure.The blood loss was not quantified; however the patient did not require other procedures as a result of this occurrence.No portion of the device remained in the patient.No adverse effects have been reported.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation a review of the dimensional verification, complaint history, device history record, drawing, manufacturing instructions, quality control, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the sheath valve was dislodged and still contained within the check-flo body.The check-flo cap was removed in order to examine the disc, and tears were observed to be present on the disc.Slit lines were also visible, but it appeared that re-healing of the silicone had occurred.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.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.Refer to section h10 for investigational findings.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7503351
• Report Number: 1820334-2018-01303
• Device Sequence Number: 275340
• Product Code: DYB
• UDI-Device Identifier: 00827002089570
• UDI-Public: (01)00827002089570(17)200123(10)7515694
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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,Followup
• Report Date (Section B): 07/24/2018

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: G08957
• Device Catalogue Number: RCFW-14.0-38-30-RB
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO WIRE