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 Codes	Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Date of Event	03/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
It was reported that at the end of a subclavian arteriogram and stenting procedure the sheath was being removed, without a dilator in place, from the right radial artery.The artery had a spasm around the sheath.The physician pulled on the sheath to remove it and the sheath broke.Pressure was held at site while the physician tried to remove the remaining piece of sheath with a clamp.The physician was unable to remove the remaining piece of sheath from the patient.Approximately 40-45 cm remained in the patient's artery.The patient was transferred to the hospital to have a surgical cut down procedure performed to surgically remove the remaining sheath and repair the tear in the artery.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.One flexor high-flex ansel guiding sheath was returned for investigation.A kink is noted at 8.2cm from the proximal end.The sheath is compressed 2cm from the distal end.Bare wire is noted at the distal end.There is no evidence to suggest the finished product was not made to specifications.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.The device is shipped with an instruction for use (ifu) that describes the intended use, the proper warnings and precautions.Precaution: "this product is intended for use by physicians trained and experienced in diagnostic and interventional techniques.Standard techniques for placement of vascular access sheaths should be employed." "do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt." per the ifu: "withdraw the sheath and dilator as a unit." the reported event may be attributed to a combination of the patient¿s clinical condition (arterial spasm) and user technique.The ifu supplied with the device instruct the user to withdraw the sheath and dilator as a unit during removal, and not to attempt to insert/withdraw the introducer when resistance is felt.Based on the information provided and results of the investigation the most likely root cause may be attributed to user technique and the patient's clinical condition(arterial spasm) during the procedure.Measures have been previously conducted to address this failure mode.We will continue to monitor 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: 6511037
• Report Number: 1820334-2017-00685
• Device Sequence Number: 556076
• Product Code: DYB
• UDI-Device Identifier: 00827002562219
• UDI-Public: (01)00827002562219(17)191221(10)7538681
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: KCFW-6.0-35-70-RB-HFANL0-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/22/2017
• Supplement Date Received by Manufacturer: 04/13/2017
• Initial Report FDA Received Date: 04/21/2017
• Supplement Report FDA Received Date: 07/13/2017
• 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: Required Intervention