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

Model Number	N/A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Patient code; no known impact or consequences to patient reported.Device code; unraveling is not labeled.The event is currently under investigation.
Event or Problem Description
During the removal of the 5fr shuttle sheath from the (b)(6) female patient with pre-existing condition of right leg pad with claudication and a tortuous anatomy, the mid portion of the sheath unraveled following an aortogram, right leg angiogram, right tibial artery balloon angioplasty.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).Correction -initial was filed within the 30 day time frame regardless of corrected date (additional information provided/updated): investigation/evaluation during the course of the investigation, a visual inspection, along with a review of the complaint history, quality control, device history record, instructions for use (ifu), manufacturing instructions, and trends of the returned product was conducted.The integrity of this device is verified 100% during the manufacturing process.An instructions for use (ifu) is provided; which states: ¿warnings: before withdrawing the sheath through tortuous anatomy, insert the introducer dilator to avoid possible breakage.¿ based on the inspection of the returned complaint device, it is likely the device experienced forces beyond its intended design.In the event description, it was noted that the patient had a "pre-existing condition of right leg pad with claudication and a tortuous anatomy." therefore, the patient's condition/anatomy could have lead to the need for excess force when removing the device.We will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera) no further action is required.
Event or Problem Description
Aortogram, right leg angiogram, right tibial artery balloon angioplasty procedure was being performed on the (b)(6) female patient; with pre-existing condition of right leg pad with claudication and a tortuous anatomy.During the removal of the 5fr shuttle sheath, the mid portion of the sheath unraveled.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5702963
• Report Number: 1820334-2016-00390
• Device Sequence Number: 413458
• Product Code: DYB
• UDI-Device Identifier: 00827002300095
• UDI-Public: (01)00827002300095(17)181006(10)6264660
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2016

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: KSAW-5.0-18/38-90-RB-SHTL-HC
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/07/2016
• Supplement Report FDA Received Date: 09/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 36 YR
• Patient Weight: 64