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

Model Number	G12266
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.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
As reported, during a procedure involving femoral access at the knee, a flexor raabe guiding sheath's "distal end" leaked blood.Another vascular sheath was used for the procedure.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures or experience any adverse effects due to the occurrence.
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.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
Additional information was received (b)(6) 2024.The hub leaked while advancing/removing the dilator through the sheath, over a cook wire guide.Resistance was not felt during insertion or removal of any device through the sheath.The patient did not require any treatment for blood loss and the procedure was completed successfully.
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: as reported, during a procedure involving femoral access at the knee, a flexor raabe guiding sheath's "distal end" leaked blood.Another vascular sheath was used for the procedure.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures or experience any adverse effects due to the occurrence.Additional information was received (b)(6) 2024.The hub leaked while advancing/removing the dilator through the sheath, over a cook wire guide.Resistance was not felt during insertion or removal of any device through the sheath.The patient did not require any treatment for blood loss and the procedure was completed successfully.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection and functional testing of the complaint device was also conducted.The complainant returned one used flexor raabe guiding sheath for investigation.Physical examination of the returned device showed only the sheath was returned, no dilator was returned.The device was leaked tested, and no leaking was noted during the test.During lab evaluation, the disc did not look to be properly seated in the hub and the disc hole appeared to be slightly out of round.The disc was removed from the hub and no damage was reported.A document-based investigation evaluation was performed.A review of the device history record found one relevant non-conformance on two devices; however, all affected product was scrapped prior to release.A review of complaint history found no additional complaints for this lot number.The customer followed all relevant instructions in the ifu related to this failure.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, ifu, and investigation of the returned device suggests that there is evidence the device was manufactured to specification.Although one relevant non-conformance was noted on a sub-assembly lot, all non-conforming product was scrapped, there are 100% inspections in place to capture this non-conformance, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot-related complaints have been received from the field.Therefore, it was concluded that there is no evidence that additional non-conforming product exists in house or in the field.Based on the information provided and the results of the investigation, cook has concluded that component failure contributed to this incident.It is possible that the dilator disrupted the silicone disc or the wire guide contributed to the leaking; however our testing could not establish this conclusion.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: 20544096
• Report Number: 1820334-2024-01411
• Device Sequence Number: 12610447
• Product Code: DYB
• UDI-Device Identifier: 00827002122666
• UDI-Public: (01)00827002122666(17)261018(10)15712927
• 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: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/25/2024

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 Model Number: G12266
• Device Catalogue Number: KCFW-6.0-38-90-RB-RAABE
• Device Lot Number: 15712927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: 10/31/2024; Not provided
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 11/25/2024; 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COOK 35X150 LOACH GUIDEWIRE.
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 84 KG