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

Model Number	G10383
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device will be returned.(b)(6).Occupation = unknown.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
A user facility reported that during balloon dilation and stent implantation within an unspecified artery in the lower extremity, a flexor balkin guiding sheath separated at the hub.Another device of the same type was use to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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
Summary of event: a user facility reported that during balloon dilation and stent implantation within an unspecified artery in the lower extremity, a flexor balkin guiding sheath separated at the hub.Another device of the same type was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, and quality control procedures was conducted during the investigation.The complaint device was not returned; therefore, a visual inspection of the device was not possible.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The complaint file, device history record, complaint history, and manufacturing documents provide evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.The product ifu warns: "if resistance is encountered during advancement of flexor sheath, assess cause of resistance and consider dilation of any restriction identified or consider alternate treatment strategy.If flexor sheath is advanced through resistance, force to remove the sheath will be higher, increasing the risk of sheath material or hub separation upon withdrawal." "reinsertion of the dilator prior to removal of flexor sheath increases the strength of the sheath and lessens the risk of device separation.If resistance is anticipated or encountered during withdrawal or flexor sheath, consider carefully reinserting the dilator prior to continuing removal." the ifu also instructs: "avoid applying traction to hub during removal." ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ a review of the manufacturer¿s instructions and quality control procedures was conducted, and no gaps were discovered.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A previously completed capa concluded that the ability to advance flexor devices into restrictive anatomies may contribute to this failure mode.Based on the information provided and the results of the investigation, cook has concluded that a definitive root cause for this event cannot be determined; although, possible causes include patient anatomy, user handling, and procedural difficulty.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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 BALKIN GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9466671
• Report Number: 1820334-2019-03107
• Device Sequence Number: 13989766
• Product Code: DYB
• UDI-Device Identifier: 00827002103832
• UDI-Public: (01)00827002103832(17)220627(10)9840153
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2020

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: 06/27/2022
• Device Model Number: G10383
• Device Catalogue Number: KCFW-6.0-38-40-RB-BLKN
• Device Lot Number: 9840153
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR