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

Model Number	436-2012X
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported event, lot number was provided, and lot history review.The sample was returned for evaluation.The result of the investigation is inconclusive for the reported balloon rupture, device incompatibility and retraction issues for the device.A root cause has not been determined.The device was labeled for single use.(b)(4).
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 436-2012x pta balloon dilatation catheter allegedly experienced material rupture, device-device incompatibility, detachment of device or device component, break, retraction problem and material separation.This report was received from a single source.This event did involve patient with no patient consequences.The patient is (b)(6) years of age, the gender is male, and the weight is (b)(6) kgs.

• Brand Name: SAVVY LONG OTW PTA CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• MDR Report Key: 9955555
• Report Number: 9616666-2020-00032
• Device Sequence Number: 2225466
• Product Code: LIT
• UDI-Device Identifier: 00801741132674
• UDI-Public: (01)00801741132674
• 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
• Report Date (Section B): 04/13/2020

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: 436-2012X
• Device Catalogue Number: 436-2012X
• Device Lot Number: CMDS0466
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 04/13/2020
• Patient Sequence Number: 1