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

Catalog Number KCFW-6.0-35-55-RB-HFANL0-HV

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2015

Event Type  malfunction  

Event Description

During a crossover procedure for treatment btk (below the knee) on a (b)(6) female pt.After the removal of the pta (passeo 14 balloon), the physician performed an overview, but noticed a thrombus in the sheath.The physician proceeds to remove the thrombus within the sheath out of the pt via aspiration.The pt is alright and treatment was successful.The physician admits, that he did not performed adequate flushing.A section of the device did remain inside the pt's body.The pt did not require any add'l procedures due to this occurrence.According to the initial reporter, the pt did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).The event is currently under investigation.More info will be available upon conclusion.

• Brand Name: FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: larry pool, mgr ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4531639
• MDR Text Key: 5538054
• Report Number: 1820334-2015-00078
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/19/2015,02/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2017
• Device Catalogue Number: KCFW-6.0-35-55-RB-HFANL0-HV
• Device Lot Number: 5196602
• Other Device ID Number: (01)00827002562318(17)170808(1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/03/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/19/2015
• Device Age: 5 MO
• Event Location: Hospital
• Date Manufacturer Received: 01/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 83