MAUDE Adverse Event Report: COOK INC FLEXOR HIGH-FLEX ANSEL 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	03/25/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being submitted past the 30 day reporting requirement as part of a retrospective review of the report that was initiated during an fda inspection.A retrospective review of the complaint record determined that this report should have been submitted as a malfunction report.In this case, no patient injury occurred; however, this may be likely to cause or contribute to a serious injury if it recurred.(b)(4).Investigation - evaluation a review of the complaint history, drawings, device history record, manufacturing instructions, quality control and visual inspection of the returned device was conducted during the investigation.Visual examination of the returned device confirmed the hub separated from the dilator shaft.The amount of flare on the proximal end of the shaft was very small, however, the device passed the qc inspections in place at the time of manufacture.It was reported that the patient's anatomy was not tortuous or calcified.The complaint device was returned therefore, an investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows 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 and the detection activities performed; the connection between the hub and dilator shaft could have been affected during shipping and handling, storage, or product use.However, a definitive root cause could not be determined.
Event or Problem Description
It was reported by the user facility that a patient underwent an unspecified procedure using a flexor high-flex ansel guiding sheath.The attending physician indicated that the tip of the introducer broke off as he was attempting to remove the dilator from the patient.The attending physician stated the separation happened outside of the patient.The patient anatomy was not tortuous or calcified.No pieces from the broken device were left in the patient nor did the patient experience any adverse effects or medical intervention due to this occurrence.No further information was provided.
Additional Manufacturer Narrative
Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• Brand Name: FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6291818
• Report Number: 1820334-2017-00237
• Device Sequence Number: 19223357
• Product Code: DYB
• UDI-Device Identifier: 00827002477018
• UDI-Public: (01)00827002477018(17)171201(10)5478887
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2017

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-12.0-35-45-RB-HFANL1-HC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/25/2015
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2017
• Supplement Report FDA Received Date: 06/14/2017
• Patient Sequence Number: 1