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

Model Number	G28322
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant products: medico's hirata 5fr angiographic catheter, endurant / medtronic stent.(b)(6).Pma/510(k) number: pre-amendment.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during a procedure to place a stent graft in a patient with an abdominal aortic aneurysm rupture, a performer introducer leaked at the hemostatic valve.Access was obtained from the left superficial femoral artery for a retrograde approach.Another manufacturer's 5 french angiographic catheter was inserted into the complaint device and blood reportedly "spouted" from the hemostatic valve.The physician pressed the valves with his finger and inserted another manufacturer's stent graft into the sheath, at which point the leak stopped.The physician continued the procedure with the complaint device, placing the stent graft and completing the procedure.There has been no report that any part of the device remained in the patient's body, that the patient required any additional procedures, or that the patient experienced any adverse effects due to this event.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation ¿ evaluation.Reviews of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control procedures, specifications, and a visual inspection as well as a functional test of the returned device were conducted during the investigation.The visual inspection of the device confirmed that one prior to use rcf 16.0fr was returned for investigation.A small amount of bio matter was located on the check flo cap/hub.No visible damage was noted.The check flo was slightly skewed on the sheath tubing.A leak tested was performed using water, and no leaks were detected.Additionally, a document-based investigation evaluation was performed.The evidence indicates the product was made to specifications.A review of the device history record showed one nonconformance which could potentially contribute to this failure mode.This nonconformance was for a leakage; however ,all affected units were scrapped and replaced prior to order completion.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, specifications, drawing, and quality control procedures were conducted, and no gaps were discovered.An ifu is provided with this device, which notes the introducers are for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices.The ifu goes on to provide the following precautions ¿this product is intended for use by physicians trained and experienced in diagnostic and interventional techniques.Standard techniques for placement of vascular access sheaths should be employed¿the maximum diameter of the instrument or catheter to be introduced should be determined to ensure its passage through the introducer.All instruments or catheters used with this product should move freely through the valve and sheath.Damage to the valve/introducer may result when the fit is tight." based on the information provided and the examination of the returned product, investigation has concluded that a root cause for this event 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.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9191451
• Report Number: 1820334-2019-02592
• Device Sequence Number: 11384307
• Product Code: DYB
• UDI-Device Identifier: 00827002283220
• UDI-Public: (01)00827002283220(17)220619(10)9771185
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2020

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: 06/19/2022
• Device Model Number: G28322
• Device Catalogue Number: RCF-16.0-38-J
• Device Lot Number: 9771185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1