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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation findings: a review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One used flexor balkin guiding sheath was returned for investigation.The sheath had a bend at 22.0 cm from the proximal end.The dilator distal end was compressed 2 mm in length and showing white stress marks 3 mm from the distal tip.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Instructions for use state, "upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
An international customer reported that when the package was opened, the user found the tip of the dilation sheath was out of shape.The user changed to another new device to use.There was reportedly no patient contact, harm, or adverse event associated with this event.

• 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: 6876599
• Report Number: 1820334-2017-02818
• Device Sequence Number: 1312761
• Product Code: DYB
• UDI-Device Identifier: 00827002103849
• UDI-Public: (01)00827002103849(17)190321(10)6828300
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/19/2017

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-7.0-38-40-RB-BLKN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2017
• Initial Report FDA Received Date: 09/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 62