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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The reported device has been received, an evaluation is in progress.
Event or Problem Description
It was reported during an unspecified procedure, the valve was detached from the joint of the flexor balkin guiding sheath in the process of withdrawing dilator.The device was replaced and the procedure was completed.There was no adverse effects experienced by the patient.No additional information has been received.
Additional Manufacturer Narrative
(b)(4).Manufacturing narrative: a review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.Manufacturing instructions for this device mention all the materials, operations, and labor procedures for a proper and correct manufacture of the device.Design verification and validation activities are implemented to ensure that this product meets design requirements and that the device meets the needs of the user.There is no evidence to suggest the product was not made to specifications.Review of the device history record shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.The device is shipped with instructions for use (ifu); specific items are addressed such as advising as to proper technique to avoid damaging the device.A flexor balkin guiding sheath was returned with the hub separated.No thread marks were noted in the flare.Compression marks in the sheath tubing were noted 0.9 mm from the proximal end and were 4 mm in length.No obstruction of the lumen was noted.The disc was intact.Based on examination of the returned device, it is possible that the physician applied excessive force on the device during the withdrawal process, which may have contributed to this event.But a definitive root cause cannot be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• Brand Name: FLEXOR BALKIN GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6396777
• Report Number: 1820334-2017-00343
• Device Sequence Number: 16306216
• Product Code: DYB
• UDI-Device Identifier: 00827002103856
• UDI-Public: (01)00827002103856(17)190405(10)6866788
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2017

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 Model Number: N/A
• Device Catalogue Number: KCFW-8.0-38-40-RB-BLKN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2017
• Supplement Report FDA Received Date: 06/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 50