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

Model Number	G11897
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 that during an endovascular aortic repair, the flexor raabe guiding sheath appeared to have no radiopaque markers making it difficult to determine accurate placement in the patient's anatomy.According to the complainant, higher doses of fluoroscopy were necessary to be able to see the distal end of the complaint device.A second flexor raabe guiding sheath from a different lot was used to successfully complete the procedure.The physician reported he has had "several" sheaths with this problem (refer to medwatch 1820334-2018-01478); however, no additional information was provided for these sheaths.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the dimensional verification, complaint history, device history record, drawing, manufacturing instructions, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the reported condition.The dilator was removed from the sheath for further examination of the distal tip.The proximal fittings were disassembled, and it was confirmed that the marker band was present on the proximal end of the tubing that had been flared.This also confirmed that the device was out of specification.Additionally, a document based investigation evaluation was performed.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, the root cause was determined to be related to the device manufacturing process.Measures are being conducted to address this failure mode.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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
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: 7523530
• Report Number: 1820334-2018-01435
• Device Sequence Number: 1862450
• Product Code: DYB
• UDI-Device Identifier: 00827002118973
• UDI-Public: (01)00827002118973(17)210322(10)NS8685854
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 03/27/2020

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: 03/22/2021
• Device Model Number: G11897
• Device Catalogue Number: KCFW-8.0-38-90-RB-RAABE
• Device Lot Number: NS8685854
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 08/02/2018; 03/27/2020
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 08/09/2018; 03/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1