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

Model Number	G31138
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number = pre-amendment.(b)(4).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, prior to a diagnostic angiography procedure, the flexor shuttle select guiding sheath was found to have a broken hub upon removal from the package.The device was flushed with saline but never made contact with the patient.According to the initial reporter, there were no patient adverse effects as a result of this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: product received date provided.Investigation ¿ evaluation.A review of the complaint history, device history record, instructions for use (ifu), manufactures instructions, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the side-arm assembly was removed by the customer and not returned with the device.No biological matter was visible on the device, but there was a clear substance at the distal tip that dissolves with water.This may be a result of the user flushing the device.The sheath tubing was separated at the proximal fitting with exposed coiling.The device does not appear to have any other surface damage.Additionally, 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 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.Furthermore, an ifu is provided with the device which states "upon removal from package, inspect the product to ensure no damage has occurred." this document review indicates there are adequate controls in place to prevent this failure mode from occurring.Inspection of this documentation did not reveal gaps in the manufacturing or quality control process.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We have notified the appropriate personnel and will continue to monitor for similar complaints.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.
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.
Event or Problem Description
No additional information regarding patient and/or event details 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.Blank fields on this form indicate the information is unknown or unavailable.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 patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: FLEXOR SHUTTLE SELECT GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7744247
• Report Number: 1820334-2018-02330
• Device Sequence Number: 1365791
• Product Code: DYB
• UDI-Device Identifier: 00827002311381
• UDI-Public: (01)00827002311381(17)210223(10)8616390
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K153430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/14/2020

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: 02/23/2021
• Device Model Number: G31138
• Device Catalogue Number: KSAW-6.0-38-90-RB-SHTL-FLEX-HC
• Device Lot Number: 8616390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 10/18/2018; 03/23/2020; 05/14/2020
• Initial Report FDA Received Date: 08/02/2018
• Supplement Report FDA Received Date: 10/31/2018; 03/23/2020; 05/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1