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 Known Impact Or Consequence To Patient (2692)
Date of Event	08/06/2018
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 flexor raabe guiding sheath was observed to be leaking at the connecting hub upon insertion into the patient's anatomy during an unknown procedure.Additional details regarding this event were not reported; however, the complainant indicated the patient did not experience any adverse effects nor require any additional procedures 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
Investigation: evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufactures instructions, quality control, and a functional test & visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the dilator was not included in the return, and that bio-matter was present on the valve.During the functional test, it was noted that water beads on the valve while flushing the sheath.Even after clamping the sheath, water continued to bead onto the valve, confirming the customer¿s testimony.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 related to this failure mode.It should be noted there were no other reported complaints for this lot number.Furthermore, a review of manufacturing documentation was performed to ensure there are adequate controls in place to prevent this type of failure mode.No gaps in the processing of this device were noted.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.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 patient/event details have been received since the previous medwatch report was sent.
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.

• 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: 7813850
• Report Number: 1820334-2018-02492
• Device Sequence Number: 1719390
• Product Code: DYB
• UDI-Device Identifier: 00827002481879
• UDI-Public: (01)00827002481879(17)210406(10)8755375
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2020

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: 04/06/2021
• Device Model Number: G48187
• Device Catalogue Number: KCFW-4.0-35-55-RB-RAABE
• Device Lot Number: 8755375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 11/01/2018; 03/19/2020
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 11/07/2018; 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1