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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Torn Material (3024)
Health Effect - Clinical Codes	Blood Loss (2597); No Code Available (3191)
Date of Event	07/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.(b)(4).The event is currently under investigation.
Event or Problem Description
Information was provided that a male patient underwent a stent aortic implant procedure.During the procedure, after passing the sheath without any difficulty by the right inguinal region in an attempt to remove the dilator, there was a circumferential and complete break of the hub.It was possible to remove the dilator from inside the sheath with tweezers, but there was a little loss of blood.Also, the extra-stiff guide that was parked in the right subclavian artery had doubled and had to be changed to continue with the procedure that was finished without difficulties.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.(b)(4).Investigation - evaluation a review of the complaint history, device history record, documentation, instructions for use (ifu), trends and quality control of the device was conducted during the investigation.The device is shipped with an instruction for use (ifu) that describes the intended use.Do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt.Upon removal from package, inspect the product to ensure no damage has occurred." the complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of 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.Based on the information provided, no product returned 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.
Event or Problem Description
Information was provided that a male patient underwent a stent aortic implant procedure.During the procedure, after passing the sheath without any difficulty by the right inguinal region in an attempt to remove the dilator, there was a circumferential and complete break of the hub.It was possible to remove the dilator from inside the sheath with tweezers, but there was a little loss of blood.Also, the extra-stiff guide that was parked in the right subclavian artery had doubled and had to be changed to continue with the procedure that was finished without difficulties.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: PERFORMER MULLINS GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5885169
• Report Number: 1820334-2016-00822
• Device Sequence Number: 879388
• Product Code: DYB
• UDI-Device Identifier: 00827002092105
• UDI-Public: (01)00827002092105(17)180615(10)5957294
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2016

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: RCFW-14.0-38-75-RB-MTS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/18/2016
• Supplement Report FDA Received Date: 11/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention