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

Model Number	G48192
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation = unknown.Pma/510(k) number = k142829.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, prior to an unknown procedure, the plastic tubing of a flexor ansel guiding sheath was found to be cracked and the sheath appeared crimped.The procedure was instead completed with a cook 6 french, 90 centimeter ansel sheath.The complaint device did not make patient contact.The device was stored hanging on a rack in the procedure room.There was no damage to the package noted.There have been no reported adverse effects to the patient.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.B1, h1: on return of device (b)(6) 2020, the sheath appeared unused.The plastic protector tube was cracked in multiple places within a 6cm section of the proximal end.The distal tip of this protector was also damaged.The sheath itself was smashed at 2mm from the check-flo cap, but no cracks, fractures, or other damage was noted to the device.There is no evidence to suggest that the observed device failure would be likely to cause or contribute to a death or a serious injury if the failure were to recur.Furthermore, there is no evidence that the device caused or contributed to a serious injury, as no life-threatening or permanently impairing injury took place, nor was intervention taken as a result of the device failure which would be required to prevent permanent impairment or damage to the patient.As such, the event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury, or reportable product malfunction.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 ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9793013
• Report Number: 1820334-2020-00553
• Device Sequence Number: 16716493
• Product Code: DYB
• UDI-Device Identifier: 00827002481923
• UDI-Public: (01)00827002481923(17)211121(10)9328851
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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): 03/05/2020

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: 11/21/2021
• Device Model Number: G48192
• Device Catalogue Number: KCFW-5.0-18/38-110-RB-ANL0-HC
• Device Lot Number: 9328851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1