MAUDE Adverse Event Report: COOK INC FLEXOR SHUTTLE SELECT GUIDING SHEATH; DYB INTRODUCER, CATHETER

Model Number	G31138
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: unknown healthcare professional.Pma/510(k) number: pre-amendment.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported via a medwatch form fda 3500a, during a scheduled carotid stent procedure involving a (b)(6) year old female patient, weighing (b)(6) pounds, "plastic" was noted to be coming out of a flexor shuttle select guiding sheath.This occurred after deployment and withdrawal of another manufacturer's embolic protection device.As the wire of the embolic device was removed, the "strange string like piece of plastic" was noted coming from the "guide catheter".The physician aspirated several times to remove any debris.All devices were removed intact, including the complaint device.Per the user, the " thin piece of plastic seems to have come from the inner lining of the shuttle sheath" and "seems to have sheared during the process".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 Manufacturer Narrative
Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures and a visual inspection of the returned device were conducted during the investigation.The complaint device was returned without the inner dilators present.The visual inspection of the returned device showed moderate biomatter present.Kinks were observed in the tubing located 7.1cm, 45.6cm, and 74.5cm from the proximal hub, none of which were sharp.The endhole was out of round but not damaged.No ¿string-like¿ piece of plastic material was returned or observed exiting the proximal or distal ends.Many unattached tnrt filaments were found throughout the entire length of the inner lumen of the sheath.A prominent straight line of missing liner was seen running the entire length of the sheath.Additionally, a document-based investigation evaluation was performed.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.The device is packaged with instructions for use, which state as precautions, ¿in order to ensure device compatibility, choose a sheath size large enough to accommodate the maximum outer diameter of any devices that will be placed through the sheath.All interventional or diagnostic instruments used with this product should move freely through the valve and sheath to avoid damage.¿ the ifu also states, ¿ensure that the inner diameter (id) of the sheath is appropriate for the maximum diameter of the instruments to be introduced." a review of the quality control procedures was also conducted.Based on the information provided and the examination of the returned product, investigation has concluded that the device failure can be attributed to inadequate quality control measures.Measures are being conducted to address this failure mode.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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
This mdr is being submitted as having information not previously reported.Additional complaint investigation and record remediation was not performed.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.
Event or Problem Description
No new patient or event information to report.
Additional Manufacturer Narrative
This mdr is being submitted as having information not previously reported.Additional complaint investigation and record remediation was not performed.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.

• Brand Name: FLEXOR SHUTTLE SELECT GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8842285
• Report Number: 1820334-2019-01868
• Device Sequence Number: 19656982
• Product Code: DYB
• UDI-Device Identifier: 00827002311381
• UDI-Public: (01)00827002311381(17)220426(10)9697526
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K153430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/14/2020

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: 04/26/2022
• Device Model Number: G31138
• Device Catalogue Number: KSAW-6.0-38-90-RB-SHTL-FLEX-HC
• Device Lot Number: 9697526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 11/27/2019; 04/09/2020; 05/14/2020
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 12/03/2019; 04/09/2020; 05/14/2020
• 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: ABBOTT EMBOSHIELD.
• Patient Age: 75 YR
• Patient Weight: 105