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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that during a femoral access procedure on a (b)(6) year old male led patient, the flexor introducer sheath device broke between the desilet and the introducer.The patient reportedly had a tortuous/calcified anatomy.The procedure was completed using another device.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, device history record, documentation, manufacturing instructions, trends, quality control and visual inspection of the returned device was conducted during the investigation.One used kcfw-8.0-38-45-rb was returned for investigation with the hub separated from the sheath.During visual inspection of the returned complaint device, it was observed that part of the flare had buckled back around the sheath.A document based investigation evaluation was also 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.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: "warnings: before withdrawing the sheath through tortuous anatomy, insert the introducer dilator to avoid possible breakage.Withdraw the sheath and dilator as a unit.Upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, examination of the returned device and the results of our investigation, a definitive root cause could not be determined.It is possible that the sheath may not have been positioned properly during proximal fitting attachment.Also, it is possible that during the procedure, the device had received force beyond it's intended design.We will continue to monitor for similar complaints.Per the health risk assessment no further action is required.
Event or Problem Description
It was reported that during a femoral access procedure on a (b)(6) male led patient, the flexor introducer sheath device broke between the desilet and the introducer.The patient reportedly had a tortuous/calcified anatomy.The procedure was completed using another device.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: FLEXOR INTRODUCER SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5993773
• Report Number: 1820334-2016-01036
• Device Sequence Number: 671694
• Product Code: DYB
• UDI-Device Identifier: 00827002096011
• UDI-Public: (01)00827002096011(17)181118(10)6389985
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2016

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-8.0-38-45-RB
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2016
• Supplement Report FDA Received Date: 12/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 DA
• Patient Weight: 90