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

Model Number	G09210
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Pma/510k # preamendment.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, during a balloon-occluded retrograde transvenous obliteration and gastrorenal shunting a performer mullins guiding sheath was "planned" to be introduced when the hub of the dilator separated.The device did not make patient contact.It is unknown how the procedure was completed.
Additional Manufacturer Narrative
Description of event: as reported, during a balloon-occluded retrograde transvenous obliteration and gastrorenal shunting a performer mullins guiding sheath was "planned" to be introduced when the hub of the dilator separated.The device did not make patient contact.It is unknown how the procedure was completed.Investigation ¿ evaluation: a document based investigation was performed including a review of complaint history, device history record, documentation, drawings, the instructions for use, manufacturing instructions, and quality control data.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 made out of specification.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ a capa was previously completed in response to an increase in dilator hub separation on rcfw mullins design.The root cause of the capa investigation was determined to be that there are inadequate controls of the flaring process for rcfw-/-mts dilators.In response to this identified root cause, the capa actions taken involved developing and implementing an in-process go / no-go gauge for 100% verification of 13fr and 14fr rcfw-/-mts dilator flare diameters.These actions were implemented on 11oct2019.The complaint device was manufactured on 19mar2019, therefore before the capa action implementation was completed.It is possible that the complaint device was manufactured with an inadequate flare as identified as a root cause in the capa investigation, however without device return, this is unable to be confirmed.Cook has concluded a definitive conclusion could not be determined.A capa was previously completed in response to an increase in dilator hub separation on rcfw mullins design.It is possible that the complaint device was manufactured with an inadequate flare as identified as a root cause in the capa investigation, however without device return, this is unable to be confirmed.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.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.
Event or Problem Description
No new patient or event information to report.

• 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: 10727364
• Report Number: 1820334-2020-01928
• Device Sequence Number: 4086930
• Product Code: DYB
• UDI-Device Identifier: 00827002092105
• UDI-Public: (01)00827002092105(17)220319(10)9603074
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2021

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: 03/19/2022
• Device Model Number: G09210
• Device Catalogue Number: RCFW-14.0-38-75-RB-MTS
• Device Lot Number: 9603074
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 01/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1