MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD SLEEK 2.0MM X 40MM L=150CM; PTA DILATATION CATHETER

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Intimal Dissection (1333)

Event Date 01/19/2017

Event Type  Injury  

Event Description

During an interventional procedure, a 2.0mm x 40mm l=150cm sleek percutaneous transluminal angioplasty (pta) balloon kinked and during repeated attempts to cross the lesion the kinked portion of the device became stuck in the blood vessel which was bleeding.  the physician stopped the bleeding and the procedure was completed.  the procedure completed on the same day with 40 minutes of prolongation.  it is unknown how the bleeding was stopped. the product will be returned for analysis.  the target lesion was right anterior tibial artery (cto).The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.The brand of sheath used in the procedure was a medikit (parent).  there was no damage noted to the box, pouch, hoop or balloon sleeve, no difficulty removing the balloon sleeve and no kinks noted on the device prior to use.The device prepped normally. a guidewire (0.014rubyhard) and a micro catheter (prominent, tokai medical) crossed the lesion.The sleek was attempted to cross but it could not cross the lesion.The physician tried to cross the catheter by pushing but he could not.Therefore the balloon was removed from the patient¿s body and confirmed that its shaft guide wire gw exit side got kinked in several portions.Furthermore bleeding to extravascular was confirmed from around exit portion of a sheath introducer (4.5f) when the lesion was checked under contrast.The physician had tried to cross the lesion several times and found that the kinked part was stick in the blood vessel and bleeding.The physician stopped the bleeding and the procedure was completed. the vessel damage was caused by the sleek device when attempting to cross and made perforation (vessel damage).The kink was occurred while it was used in the patient and that kink was confirmed after the removal of the complaint product. additional procedural details were requested but are unknown.

• Brand Name: SLEEK 2.0MM X 40MM L=150CM
• Type of Device: PTA DILATATION CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD; enniscorthy; co. wexford ; EI
• MDR Report Key: 6325708
• MDR Text Key: 67248508
• Report Number: 1016427-2017-00175
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 4252004X
• Device Lot Number: 50114062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2017
• Distributor Facility Aware Date: 01/19/2017
• Device Age: 27 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/13/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: SEE B5
• Patient Outcome(s): Life Threatening; Disability