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

Model Number	G11638
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfg = device evaluation has begun; however, a conclusion is not yet available.Concomitant = device cook amplatz extra stiff floppy tip 180cm 0.035in wire.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 initially reported, a flexor raabe guiding sheath would not advance over a wire guide.Another device was used to complete the procedure.Upon return and initial evaluation of the complaint device, an opaque material came out of the proximal end of the device as a wire guide was pushed through.The material was described as light, flaky, and thin.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
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: as initially reported, a flexor raabe guiding sheath would not advance over a wire guide.Another device was used to complete the procedure.Upon return and initial evaluation of the complaint device, an opaque material came out of the proximal end of the device as a wire guide was pushed through.The material was described as light, flaky, and thin.Investigation ¿ evaluation.A visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, drawings, the instructions for use, manufacturing instructions, quality control data, and specifications.The complainant returned a kcfw-6.0-38-55-rb-raabe in a prepped condition with dilator inserted to cook for investigation.Physical examination of the returned device showed: there was a small amount of biological material on the check-flo valve.There was no visible damage to device.A 0.038" wire was inserted through the end hole of the dilator and exited the proximal fitting with a smooth transition through the dilator.A small piece of opaque material came out of the proximal end on the wire.The reported failure was not evident to investigators however the opaque material found changed the nature of the complaint.A review of the device history record found one non-conformances related to the reported failure mode.The non-conformance was for foreign matter in the package which was reworked.A review of complaint history records shows one other complaint associated with the complaint device lot, though the failure did not have the same failure mode.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied upon removal from package, inspect the product to ensure no damage has occurred." a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Based on the provided evidence and the completed investigation, cook has concluded manufacturing failure contributed to this incident.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.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 new patient or event information to report.

• 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: 10483320
• Report Number: 1820334-2020-01608
• Device Sequence Number: 1218543
• Product Code: DYB
• UDI-Device Identifier: 00827002116382
• UDI-Public: (01)00827002116382(17)230318(10)13063831
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/11/2021

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: 03/18/2023
• Device Model Number: G11638
• Device Catalogue Number: KCFW-6.0-38-55-RB-RAABE
• Device Lot Number: 13063831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1