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

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Occupation: lead tech.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 a flexor rtps guiding sheath was required for a filter retrieval procedure in a (b)(6) old female patient.As the tech was loading the snare onto the wire, the physician noticed an excessive amount of blood coming from the "diaphragm" of the sheath.The faulty sheath was removed and replaced to successfully complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: b3.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.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.
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
Investigation ¿ evaluation: (b)(6) hospital (united states) informed cook a flexor rtps guiding sheath began leaking at the valve during a filter retrieval.The customer reported that as the tech was loading an unknown goose snare onto a bentson wire guide, the physician noticed an "excessive" amount of blood coming from the check-flo valve on the sheath.The sheath was removed and replaced and the procedure was completed without adverse effects to the patient.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control, were conducted during the investigation.The customer did not return the device or provide photos of the failure.Therefore, no visual inspection of the device was performed.Additionally, a document-based investigation evaluation was performed.The risks associated with these devices are acceptable when weighed against the benefits.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The product labeling and instructions for use (ifu) supplied with the device were reviewed for the reported failure mode.The instructions for use [t_flexor_rev1] state the following: "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 device history record (dhr) was reviewed.The review revealed no related nonconformances.A complaints database search was performed.There were no additional complaints on the lot.There is no evidence of nonconforming material in house or in the field.The customer reported that the valve leaked when the sheath was in the patient over a wire guide, and prior to introducing a snare.It is possible that the valve was damaged or torn in the procedure, but this was not confirmed.Based on the information provided, no visual inspection of the device, and the results of the investigation, it was concluded a component failure without manufacturing deficiency contributed to the failure.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.

• Brand Name: FLEXOR RTPS GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10185152
• Report Number: 1820334-2020-01172
• Device Sequence Number: 16898360
• Product Code: DYB
• UDI-Device Identifier: 00827002130814
• UDI-Public: (01)00827002130814(17)220610(10)9799065
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142829
• 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): 07/29/2020

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: 06/10/2022
• Device Model Number: N/A
• Device Catalogue Number: KCFW-10.0-35-RB-RTPS-100
• Device Lot Number: 9799065
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 07/13/2020; 07/23/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 07/15/2020; 07/29/2020
• 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: BENTSON WIRE, GOOSE-NECK SNARE
• Patient Age: 65 YR
• Patient Weight: 171