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

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

Device Problem Occlusion Within Device (1423)

Patient Problem Treatment with medication(s) (2571)

Event Date 01/02/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015, the physician was performing a crossover, leg therapy pta (percutaneous transluminal angioplasty) on a (b)(6) female pt when it was noticed that a thrombus was built in the introducer.The physician does not remember the details very well.However, he thinks it came to a thrombus formation in the sheath (the physician stated, that maybe they had not flushed enough with naci).Itf he would put the pta catheter (passeo14) over the cruiser-wire 0.014 inch, it would have pushed the thrombus into the aortic anterior and occluded.So the physician performed lyses therapy, which was successful.A section of the device did not remain inside the pt's body.The pt did require lyses leg therapy procedure 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 indo 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: 4531656
• MDR Text Key: 18546971
• Report Number: 1820334-2015-00072
• 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: Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/19/2015

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: Other
• Device Expiration Date: 08/08/2017
• Device Catalogue Number: KCFW-6.0-35-55-RB-HFANL0-HC
• Device Lot Number: 5196602
• Other Device ID Number: (01)00827002562318(17)170808(1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/02/2015
• 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: 08/21/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 73