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

Model Number G09190

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Occupation: distributor.Pma/510(k) number: pre-amendment.Investigation-evaluation: reviews of the complaint history, device history record, instructions for use (ifu), quality control, and specifications were conducted during the investigation.The device was not returned for evaluation; however, the customer provided photos of the complaint device.The photos show the device is twisted or accordioned at the proximal end with bends also noted.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.There were no identified gaps in the quality controls or inspection procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The product ifu cautions, ¿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 with this product should move freely through the valve and sheath.Damage to the valve/introducer may result when the fit is tight.When inserting, manipulating or withdrawing a device through an introducer always maintain introducer position.Do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt.¿ the ifu also instructs, ¿upon removal from package, ensure the inner diameter of the introducer is appropriate for the maximum diameter of the instrument or catheter to be introduced." based on the information provided and the results of the investigation, cook has concluded that a definitive cause for this failure could not be determined.Possible causes such as patient anatomy, procedural factors, or interaction with the occluder device cannot be ruled out.The risk analysis for this failure mode was reviewed, and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.

Event Description

As reported, during an unspecified procedure involving occlusion of the "cia", another manufacturer's occluder was difficult to remove from a kinked performer mullins guiding sheath.The sheath was prepared per the instructions for use and was used as a guide for the occlusion device.The device was reportedly repositioned after the first release; however upon the second attempt it was not possible to reinsert the device into the sheath.The sheath became "deformed with twisting on its own axis" and the diameter became diminished.The occluder was removed with difficulty and inserted into a larger sheath.Another manufacturer's sheath 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.

• Brand Name: PERFORMER MULLINS GUIDING SHEATH
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jennifer canada ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 10057028
• MDR Text Key: 198531735
• Report Number: 1820334-2020-00955
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002091900
• UDI-Public: (01)00827002091900(17)191026(10)7390168
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2019
• Device Model Number: G09190
• Device Catalogue Number: RCFW-9.0-38-75-RB-MTS
• Device Lot Number: 7390168
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 4 YR