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

Model Number	G08957
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation = non-healthcare professional.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 reported, when removing the device from the packaging in preparation for endovascular repair of an abdominal aortic aneurysm, the valve of a performer introducer sheath became dislodged.Per the reporter "when the device was taken out of the packaging, the dilator pushed the valve into the body of the sheath." despite this observation, the device was introduced into the patient via the left femoral artery.The sheath was reported to be in place for "seconds", resulting in a blood loss of less than 10 milliliters.The complaint device was removed, and another cook device was used to complete the procedure successfully.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation a review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, trends, quality control, and visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device confirmed that the silicone disk was torn and in the wrong position.No other damage was noted to the device.Investigators were able to recreate the reported failure mode.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 three nonconforming events which could contribute to this failure mode; however, these non-conformances were scrapped.It should be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufactures instructions and quality control procedures were conducted, and no gaps were discovered.The product instructions for use cautions the user no to attempt to insert or with draw the wire guide and/ or introducer if resistance is felt and to inspect the product to ensure no damage has occurred upon removal from package.Based on the information provided and the examination of the returned product, investigation has concluded a definitive conclusion 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 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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: 8515778
• Report Number: 1820334-2019-00947
• Device Sequence Number: 2006274
• Product Code: DYB
• UDI-Device Identifier: 00827002089570
• UDI-Public: (01)00827002089570(17)211207(10)9330304
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2019

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: 12/07/2021
• Device Model Number: G08957
• Device Catalogue Number: RCFW-14.0-38-30-RB
• Device Lot Number: 9330304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 05/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1