MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD SAVVY LONG 2.0X220MM L=120CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4362022L
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Post dilation, it was difficult to remove the savvy long balloon catheter via the sheath as it became elongated and detached from the catheter.There was no patient injury.The device was removed from the patient with use of a goose neck snare.The target lesion is the anterior tibial artery which was moderately calcified with a combination of stenoses and occlusions, approx 20 cm in length.The device was prep according to the instruction for use with no defects noted during prep.A constant and dedicated saline source was utilized through the balloon during prep.There were no difficulties removing the product from the hoop, the protective balloon cover, the 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.A competitor's contrast media and inflation device was used with a ration of sixty/forty.The inflation device was successfully used with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.The catheter has never been in an acute bend.A 4fr brite tip sheath was used and then upsized to 6fr brite tip sheath.There were no difficulty inflating the balloon.The device is available for analysis as the customer has kept the balloon.No other information was provided.

• Brand Name: SAVVY LONG 2.0X220MM L=120CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD; enniscorthy; co. wexford 0000 ; EI 0000
• MDR Report Key: 8520326
• Report Number: 1016427-2019-02729
• Device Sequence Number: 1278133
• Product Code: LIT
• UDI-Device Identifier: 00801741132742
• UDI-Public: 00801741132742
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K072947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 04/16/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 4362022L
• Device Catalogue Number: 4362022L
• Device Lot Number: CMCV0276
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/20/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention