MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD SLEEK OTW 5.0X10 X 150 SHAFT; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4265010X
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
As the balloon of a 5mm x 10cm x 150cm sleek over-the-wire (otw) percutaneous transluminal angioplasty (pta) balloon catheter (bc) was being withdrawn from the patient, it got caught up on the tip of the 6f non-cordis sheath and wasn¿t able to be removed.As further attempts were made to withdraw the sleek balloon, the entire balloon separated from the shaft and remained in the patient¿s tibial artery.The remaining shaft was removed over the wire and the patient was sent to surgery after failed attempt at snaring the balloon.The balloon was removed by a vascular surgeon in the operation room (or) by cutdown after being transported to the hospital.The patient is doing well with no issues.The device was stored and handled as per the instruction for use (ifu).There was no damage noted to the packaging of the device.There were no anomalies noted when removed from the package.The device was opened in sterile field.There was no difficulty removing the product from the hoop, the protective balloon cover, stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product the product into the patient.The intended procedure/target lesion was the superficial femoral artery (sfa) from pedal access.The lesion was severely calcified, 99 percent stenosed and had moderate tortuosity.The device was used for a chronic total occlusion.The device was not resterilized.There were no anomalies noted during prep.The device was not inserted through a stopcock instead of a hemostatic valve.The sleek balloon was inserted through the 6f non-cordis sheath in pedal/tibial artery on a retrograde access and was advanced to the superficial femoral artery (sfa) to post-dilate a 7 x 150 smart stent.It was the same balloon used to pre-dilate area of this stent.After the sleek balloon was advanced over a 300cm stabilizer extra support (xs) wire to the area, it was inflated to nominal pressure and was deflated.The device will be returned for analysis.

• Brand Name: SLEEK OTW 5.0X10 X 150 SHAFT
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD; moyne upper; enniscorthy; co. wexford Y21 Y 9T0; EI Y21 Y9T0
• MDR Report Key: 11125058
• Report Number: 1016427-2021-04697
• Device Sequence Number: 4422166
• Product Code: LIT
• UDI-Device Identifier: 00801741133992
• UDI-Public: 00801741133992
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K102035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/06/2021
• Report Date (Section F): 01/06/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 4265010X
• Device Catalogue Number: 4265010X
• Device Lot Number: CMEV0264
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/09/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/06/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 01/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 300CM STABILIZER XS WIRE; 7 X 150 SMART STENT; TERUMO 6F GLIDESHEATH
• Outcome Attributed to Adverse Event: Required Intervention