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

Model Number	G07816
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: technologist.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
It was reported that during an unknown procedure, two performer mullins guiding sheaths separated during the same case.There has been no report that any part of the device remained in the patient's body, that the patient required any additional procedures, or that the patient experienced any adverse effects due to this event.Additional information regarding event details, patient anatomy and outcome has been requested, but is not available at this time.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation evaluation: a review of the manufacturing instructions, quality control, device history record, instruction for use, and complaint history was conducted during the investigation.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.A review of the device history record showed one nonconforming event which could contribute to this failure mode.However, there is 100% inspection for this prior to lot release and the identified device was scrapped.It should be noted there is one other reported complaint for this lot number for an unrelated failure mode.Based on the information provided, no product returned, and the results of the investigation, a definitive root cause could not be determined.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.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.
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
Additional information: the procedure involved in this event was pulmonary dilation with balloon angioplasty.The patient's medical history included congenital heart disease.The anatomy of the patient was not unusual at the location of sheath insertion and resistance was not noted at the time of removal.The patient experienced 10cc of blood loss as a result of the hub separation from the shaft of the device.The separated portion of the device was immediately removed from the patient and there was no consequence to the patient.No additional procedures were required as a result of this event.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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.
Event or Problem Description
Additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 8236539
• Report Number: 1820334-2019-00077
• Device Sequence Number: 1886929
• Product Code: DYB
• UDI-Device Identifier: 00827002078161
• UDI-Public: (01)00827002078161(17)211003(10)9209624
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 03/13/2019

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: 10/03/2021
• Device Model Number: G07816
• Device Catalogue Number: RCFW-7.0-38-63-RB-MTS
• Device Lot Number: 9209624
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/27/2018
• Supplement Date Received by Manufacturer: 01/14/2019; 03/11/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 01/14/2019; 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1