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

Model Number	G11571
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	12/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 chb guiding sheaths separated at the hub.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.
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
(b)(6) reviews of the complaint history, device history record, instructions for use (ifu), manufactures instructions, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one rcfw-5.0-25-45-rb-chb was returned with dilator inserted through the check flo for investigation.The snap fit connector cap was separated from the check flo body.The proximal flare was caught in the connector cap and didn¿t appear to have been pulled through the cap.There was no damage to the sheath.There was however, minimal biological matter on the hub of the sheath and inside the connector cap.The dilator and sheath endholes were in round.Upon additional evaluation, the investigator attempted to manually snap the connector cap back onto the check flo body, but was unsuccessful.Additionally, 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 no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufactures instructions and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with the device, which states "upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be established.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.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
Please see h10 for additional information received 24jan2019.
Additional Manufacturer Narrative
B5: additional information was received from the physician's assitant via the cook representative on 24jan2019.The procedure was a heart biopsy.The complaint device separated as it was being placed on the wire prior to entering the patient's anatomy.No resistance was felt.Since the device never made patient contact, no portion of it was left inside the anatomy.The patient did not experience any adverse effects as a result of this occurrence.The complaint device was discarded and a new one used successfully.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.

• Brand Name: PERFORMER CHB GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8236504
• Report Number: 1820334-2019-00067
• Device Sequence Number: 16420707
• Product Code: DYB
• UDI-Device Identifier: 00827002115712
• UDI-Public: (01)00827002115712(17)211030(10)9274773
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/29/2019

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: 10/30/2021
• Device Model Number: G11571
• Device Catalogue Number: RCFW-5.0-25-45-RB-CHB
• Device Lot Number: 9274773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Initial Date Received by Manufacturer: 01/03/2019
• Supplement Date Received by Manufacturer: 01/24/2019; 03/27/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 01/28/2019; 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN GUIDE WIRE