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

Model Number	G29989
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	08/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation = non-healthcare professional- lab manager.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
As reported, upon removal of a flexor ansel guiding sheath at the completion of an unspecified procedure for peripheral artery disease, the hub separated from the sheath.Access was obtained in the right common femoral artery and the target location was below the knee.Another manufacturer's balloon and atherectomy device were used during the procedure, as well as a cook amplatz extra-stiff support wire guide.The patient did not have calcified, tortuous, or scarred anatomy.The sheath was able to be removed by hand and no further intervention was required.The patient's outcome was reported as "good".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 Manufacturer Narrative
Event summary: as reported, upon removal of a flexor ansel guiding sheath at the completion of an unspecified procedure for peripheral artery disease, the hub separated from the sheath.Access was obtained in the right common femoral artery and the target location was below the knee.Another manufacturer's balloon and atherectomy device were used during the procedure, as well as a cook amplatz extra-stiff support wire guide.The patient did not have calcified, tortuous, or scarred anatomy.The sheath was able to be removed by hand and no further intervention was required.The patient's outcome was reported as "good".Investigation - evaluation.Reviews of the complaint history, device history record, drawing, instructions for use, manufacturing 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.A document-based investigation evaluation was thus performed.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted that there were no other reported complaints for this lot number.Reviews of the manufacturing instructions, quality control procedures, and drawings were also conducted, and no gaps were discovered.The available information provides objective evidence to support that the device was manufactured to specification.The device is packaged with instructions for use, which state, "avoid applying traction to hub during removal." the ifu further notes, ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ a previously closed capa determined that forced advancement through restrictive anatomies is a primary contributing factor to sheath hub separations.Based on the information provided, investigation has concluded that a cause for the device failure could not be determined.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 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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: FLEXOR ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9010145
• Report Number: 1820334-2019-02283
• Device Sequence Number: 2377684
• Product Code: DYB
• UDI-Device Identifier: 00827002299894
• UDI-Public: (01)00827002299894(17)220625(10)9834462
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2020

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: 06/25/2022
• Device Model Number: G29989
• Device Catalogue Number: KCFW-6.0-18/38-90-RB-ANL1-HC
• Device Lot Number: 9834462
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/29/2019
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ABBOTT BALLOON, SPECTRANETICS ATHERECTOMY LASER; ABBOTT BALLOON, SPECTRANETICS ATHERECTOMY LASER