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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that while performing a melody valve procedure using a performer mullins guiding sheath, the hub of the dilators broke off.This happened twice in the same case.The first device broke when the scrub was assembling it.The second device broke when the physician was removing the sheath from the patient.This medwatch is for the first device.Please see medwatch with mfr report number 1820334-2017-00957 for the second device.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
A review of the dimensional verification, complaint history, device history record, documentation, drawing, instructions for use (ifu), quality control and visual inspection of the returned device was conducted during the investigation.The performer mullins guiding sheath was returned with the proximal hub separated from the dilator shaft.No other damage was noted to the dilator.In addition, there were two 12 french (fr) dilators returned.One 12 fr was in a sealed package and the other was in an opened package.No damage was noted to the additional dilators.The sheath was noted to have kinks at 11.9 centimeters (cm), 26.7 cm and 33.0 cm from the proximal hub.The i.D of connector cap measured 0.194" and the flare was measured at two different angles.Review of device history record shows no nonconforming events which could contribute to this failure mode.There was one other reported complaint for this lot number.Per the ifu: "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." based on the information provided and results of the investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.

• 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: 6563183
• Report Number: 1820334-2017-00956
• Device Sequence Number: 16370096
• Product Code: DYB
• UDI-Device Identifier: 00827002092105
• UDI-Public: (01)00827002092105(17)191028(10)7399526
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 07/17/2017

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: N/A
• Device Catalogue Number: RCFW-14.0-38-75-RB-MTS
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/20/2017
• Supplement Date Received by Manufacturer: 07/07/2017
• Initial Report FDA Received Date: 05/12/2017
• Supplement Report FDA Received Date: 07/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1