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

Model Number	G12242
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	03/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, during an unknown procedure, a part of the hemostatic valve on the flexor raabe guiding sheath separated.According to the physician, the complaint device was inserted in the patient's anatomy and the external tip of the introducer that is connected to the hemostatic valve "released".It was necessary to remove the complaint device and replace it with another, although is not known if it was another of the same device.According to the initial reporter, the patient did not experience any adverse effects as a result of this occurrence nor require any additional interventions.A portion of the device did not remain in the patient's anatomy.According to the complainant, the complaint device will not be returned to the manufacturer to aid in the investigation.
Additional Manufacturer Narrative
Reviews of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control, and specifications of the device as well as a personnel interview 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.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Additionally, reviews of the manufacturer¿s instructions, drawings, specifications, and quality control procedures were conducted, and no gaps were discovered.Furthermore, an ifu is provided with the device, which states ¿before withdrawing the sheath through tortuous anatomy, insert the introducer dilator to avoid possible breakage.¿ it goes on to recommend inserting the introducer dilator over the wire into the sheath.Then, withdrawing the sheath and dilator as a unit.Based on the information provided, no product returned, and the fact that there is no evidence to suggest the device was not manufactured to specification, investigation has concluded that this event cannot be traced to the device but likely to the patient¿s anatomy.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.
Event or Problem Description
No new patient or event information received since the last report was submitted.
Additional Manufacturer Narrative
This mdr is being submitted as having information not previously reported.Additional complaint investigation and record remediation was not performed.Blank fields on this form indicate the information is unknown or unavailable.Corrected information: g5.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: 8488208
• Report Number: 1820334-2019-00797
• Device Sequence Number: 1870740
• Product Code: DYB
• UDI-Device Identifier: 00827002122420
• UDI-Public: (01)00827002122420(17)210119(10)8521280
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2020

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: No Information
• Device Expiration Date: 01/19/2021
• Device Model Number: G12242
• Device Catalogue Number: KCFW-8.0-38-55-RB-RAABE
• Device Lot Number: 8521280
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 06/18/2019; 03/26/2020
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 06/20/2019; 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1