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

Model Number	G12242
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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, the "side port" disconnected from the flexor raabe guiding sheath.The complaint device was placed in the patient's groin.No damage was noted at this time.When the physician attempted to flush the complaint device, the side port disconnected.The complaint device was then removed and the procedure continued with a new similar device.Per the initial reporter, no additional information is available.No patient adverse effect has been reported.
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
A review of the complaint history, device history record, documentation, instructions for use, dimensional verification, manufacturing instructions, specifications, drawing, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the valve was separated from the sheath.The sheath surface was without damage.There was no damage or non-conformances noted internally.The inner diameter of the connector cap was found to be within desired specifications.The flare was out of round; however passed the flare gauge.This could have occurred during the hub separation, therefore cannot be confirmed as manufacturing related.There is nothing to indicate that the device was manufactured out of specification.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 be noted there were no other reported complaints for this lot number.Furthermore, a review of the manufactures instructions, verification testing, and quality control procedures was conducted, and no gaps were discovered.Moreover, instructions for use are provided with this device, which state: "before withdrawing the sheath through tortuous anatomy, insert the introducer dilator to avoid possible breakage." 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 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.
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 additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: FLEXOR RAABE GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8222006
• Report Number: 1820334-2019-00079
• Device Sequence Number: 277219
• Product Code: DYB
• UDI-Device Identifier: 00827002122420
• UDI-Public: (01)00827002122420(17)210215(10)8589990
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/17/2020

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: 02/15/2021
• Device Model Number: G12242
• Device Catalogue Number: KCFW-8.0-38-55-RB-RAABE
• Device Lot Number: 8589990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 03/27/2019; 03/17/2020
• Initial Report FDA Received Date: 01/07/2019
• Supplement Report FDA Received Date: 03/27/2019; 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1