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

Catalog Number KCFW-6.0-35-55-RB-HFANL1-HC

Device Problems Unraveled Material (1664); Split (2537)

Patient Problem No Code Available (3191)

Event Date 10/24/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

It was reported that during a percutaneous transluminal angioplasty in the superficial femoral artery, the flexor high-flex ansel guiding sheath split and unraveled in the patient.The physician had to cut down to retrieve the remainder of the sheath, and inflate a balloon at the site so pieces would not travel distally and cause damage.The patient had lesion in their superficial femoral artery prior to the procedure.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

The patient was reported to have the following pre-existing condition prior to the procedure: peripheral artery disease (pad).The patient had a calcified superficial femoral artery (sfa) lesion being treated which was accessed through the groin, going up and over with the sheath.A rosen wire and 0.035 inch diameter balloon were utilized through the flexor high-flex ansel guiding sheath.The sheath unraveled upon removal of the sheath from the groin.The physician stated that while the rosen wire was in place, there was resistance over the wire pulling the sheath back, requiring the wire to be removed.The event is currently under investigation.A supplemental report will be provided upon conclusion.

Manufacturer Narrative

Investigation - evaluation: a review of documentation, instructions for use (ifu), specifications, and quality control was conducted during the investigation.The complaint device was not returned to aid the investigation; however, images of the failure were provided.In the images provided, the dilator is not inserted into the sheath of the device.The sheath tubing has separated into two sections exposing the underlying coil on the proximal separated portion.The coiling appears to be elongated.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 was unable to be performed as the lot number for the device was not available.A complaint history search was also unable to be performed due to the lack of a lot number.It was reported that the patient's anatomy was calcified.The calcification could have damaged the device and/or caused the device to become stuck, leading to the material separating and unraveling during removal of the device.The dilator was not inserted during removal of the sheath, which could have contributed to the failure mode as well.Per the ifu, the sheath and dilator are to be withdrawn as a unit.Dilators are stiff, thick-walled catheters which provide support to the sheath.Therefore, if the dilator is not inserted, the support for the sheath is not sufficient and could cause the sheath to separate and eventually unravel.Additionally, the physician stated that he removed the rosen wire in place as he felt resistance over the wire when pulling the sheath back.The ifu states the following: "do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt." based on the information provided, no product returned, and the results of our investigation, the root cause of this event is likely attributed to user technique or human anatomy.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6988261
• MDR Text Key: 90605078
• Report Number: 1820334-2017-03735
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: KCFW-6.0-35-55-RB-HFANL1-HC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2017
• 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