MAUDE Adverse Event Report: COOK INC FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Thrombus (2101); No Code Available (3191)
Date of Event	04/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has been requested and not yet received.The event is currently under investigation.
Event or Problem Description
It was reported during a right leg percutaneous transluminal angioplasty (pta) procedure, there was a complication with a 5 french ansel high flex sheath that was unable to be retracted/removed from the patient.It was reported that plans were to take the patient to surgery although the patient was reported to be doing fine.The plan was to do a cut down procedure of the effected leg and remove the sheath during surgery.It was reported that the vascular surgeon had noted when pressing on the patient's groin area, a sizeable chunk of calcium.On (b)(6) 2017, the patient underwent a cut down procedure.It was noted that the calcium chunk was holding the sheath.The surgeon was able to remove and release the sheath by removing the calcium.Post procedure it was noted that due to the duration of waiting to undergo the cut down procedure, the leg had thrombosed.The patient was placed on antibiotic therapy.The physician will monitor the patient to determine when the by-pass procedure can be scheduled.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.The follow-up bypass procedure had been performed and the patient is reportedly doing okay.A review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, and quality control was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.However, a document-based investigation was performed.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.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.Based on the available information, it is reasonable to suggest that the leading cause to this event may be associated with the pre-existing patient condition of heavy calcification in the groin.However, a definitive root cause could not conclusively be determined.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: 6561746
• Report Number: 1820334-2017-00955
• Device Sequence Number: 10964814
• Product Code: DYB
• UDI-Device Identifier: 00827002562301
• UDI-Public: (01)00827002562301(17)200202(10)7643029
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2017

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-5.0-35-55-RB-HFANL0-HC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/19/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2017
• Supplement Report FDA Received Date: 06/21/2017
• 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
• Patient Age: 69 YR