MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD SLEEK OTW 2.0X15 X 150 SHAFT; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4262015X
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During use, the 2.0x150mm sleek over the wire balloon catheter fractured in an anterior tibial artery.The balloon was caught on a piece of calcium and would not dislodge.This caused the patient to be transferred to (b)(6) hospital for surgical remove of the balloon.There were no other reported complications.The device will not be returned for analysis.

• Brand Name: SLEEK OTW 2.0X15 X 150 SHAFT
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD; enniscorthy; co. wexford ; EI
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD; enniscorthy; co. wexford ; EI
• Manufacturer Contact: karla castro ; 7863138372
• MDR Report Key: 13623257
• Report Number: 1016427-2022-05393
• Device Sequence Number: 5199595
• Product Code: LIT
• UDI-Device Identifier: 00801741133619
• UDI-Public: 801741133619
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 02/28/2022
• Report Date (Section F): 02/28/2022

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: 06/30/2023
• Device Model Number: 4262015X
• Device Catalogue Number: 4262015X
• Device Lot Number: CMEU0118
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/03/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Date Report Sent to FDA: 02/28/2022