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

Model Number	G48187
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer name and address: (b)(6).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.
Event or Problem Description
As reported, during an unknown procedure, a flexor raabe guiding sheath leaked at the valve as the user flushed the sheath.The device could not be used.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.Additional information has been requested.
Additional Manufacturer Narrative
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.
Event or Problem Description
Additional information was received 26jun2022.The silicone disc leaked during device preparation.Nothing was in the lumen of the sheath when the leak was noted.
Event or Problem Description
No additional information has been received since the last report was submitted.
Additional Manufacturer Narrative
Summary of event: as reported, during preparation for an unknown procedure, a flexor raabe guiding sheath leaked at the valve/silicone disc as the user flushed the sheath.The device could not be used.Nothing was in the lumen of the sheath when the leak was noted.The patient did not require any additional procedures or experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.Photos provided by the customer show that the silicone disc was present.A document-based investigation evaluation was performed.There have been no other reported complaints for this lot number.One relevant non-conformance was noted on the lot; however, all affected product was scrapped, and there are 100% inspections for this non-conformance.The product ifu states, ¿using the side-arm of the valve, flush the sheath by filling the sheath assembly completely with heparinized saline.¿ the information provided upon review of the dmr, dhr, ifu, and inspection of photos provided by the customer provides evidence that the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that a component failure unrelated to manufacture or design deficiencies contributed to this incident.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 RAABE GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 14685153
• Report Number: 1820334-2022-01052
• Device Sequence Number: 17347917
• Product Code: DYB
• UDI-Device Identifier: 00827002481879
• UDI-Public: (01)00827002481879(17)250121(10)NS14488589
• Combination Product (Y/N): N
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/02/2022

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: 01/21/2025
• Device Model Number: G48187
• Device Catalogue Number: KCFW-4.0-35-55-RB-RAABE
• Device Lot Number: NS14488589
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/07/2022
• Supplement Date Received by Manufacturer: 06/26/2022; 08/09/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 06/30/2022; 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown