MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. SAVVY LONG OTW PTA CATHETER; PTA DILATATION BALLOON CATHETER

Model Number	436-3015L
Medical Device Problem Codes	Difficult to Remove (1528); Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 436-3015l.Pta dilatation balloon catheter allegedly experienced difficult to remove and retraction problem.This report was received from a single source.This event did involve patient with no reported patient injury.The patient is (b)(6) of age, the gender is male, and the weight is (b)(6).
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the evaluation was inconclusive for difficult to remove and retraction problem, however, the evaluation is confirmed for guidewire related device-device incompatibility.Based upon the available information, a definitive root cause is unknown.The device is labeled for single use.H10: g4, h6 (device code - (b)(4).
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 436-3015l.Pta dilatation balloon catheter allegedly experienced difficult to remove and retraction problem.This report was received from a single source.This event did involve patient with no reported patient injury.The patient is 58 years of age, the gender is male, and the weight is 62kgs.

• Brand Name: SAVVY LONG OTW PTA CATHETER
• Common Device Name: PTA DILATATION BALLOON CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• MDR Report Key: 9583253
• Report Number: 9616666-2020-00007
• Device Sequence Number: 10877477
• Product Code: LIT
• UDI-Device Identifier: 00801741132926
• UDI-Public: (01)00801741132926
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 436-3015L
• Device Catalogue Number: 436-3015L
• Device Lot Number: CMDS0579
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 04/01/2020
• Patient Sequence Number: 1