MAUDE Adverse Event Report: COOK INC FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH; DYB INTRODUCER, CATHETER

Model Number	G49043
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
As reported, during an unknown procedure, the side-arm of a flexor high-flex ansel guiding sheath leaked.As a result, the side arm of the device reportedly thrombosed.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.Per the initial reporter, additional information will not be provided.
Additional Manufacturer Narrative
Initial report: as reported, during an unknown procedure, the side-arm of a flexor high-flex ansel guiding sheath leaked.As a result, the side arm of the device reportedly thrombosed.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.Per the initial reporter, additional information will not be provided.Investigation ¿ evaluation.Reviews of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturer¿s instructions, and quality control procedures of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device history record revealed one potentially related non-conformance for leakage.However, it should be noted there were no other reported complaints for this lot number.As there are no other lot related complaints that have been received from the field, adequate inspection activities have been established and non-conforming product has been identified and scrapped during the manufacturing process it was concluded that there is evidence to suggest all items in the lot in house or in the field are manufactured to specification.Furthermore, reviews of the manufacturer¿s instructions, drawing, and quality control procedures were conducted, and no gaps were discovered.An ifu is provided with this device, which states upon removal from package, inspect the product to ensure no damage has occurred.Based on the information provided and no product returned, investigation has concluded that a root cause for this event 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 information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9884499
• Report Number: 1820334-2020-00694
• Device Sequence Number: 2784713
• Product Code: DYB
• UDI-Device Identifier: 00827002490437
• UDI-Public: (01)00827002490437(17)220114(10)9442468
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2020

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: 01/14/2022
• Device Model Number: G49043
• Device Catalogue Number: KCFW-7.0-35-55-RB-HFANL1-HC
• Device Lot Number: 9442468
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1