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

Model Number	436-2015X
Medical Device Problem Codes	Inflation Problem (1310); Retraction Problem (1536); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided and a lot history review was performed.The device was returned to bd for evaluation.The investigation is confirmed for material rupture.Based on the information provided, the definitive root cause is unknown.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 436-2015x pta balloon dilatation catheter allegedly experienced inflation issue, material rupture, and retraction problem.This information was received from one source.This malfunction did involve a patient with no patient injury.The patient was a (b)(6) female that weighed (b)(6).

• 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: 9211429
• Report Number: 9616666-2019-00131
• Device Sequence Number: 19570812
• Product Code: LIT
• UDI-Device Identifier: 00801741132704
• UDI-Public: (01)00801741132704
• 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): 10/18/2019

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: 436-2015X
• Device Catalogue Number: 436-2015X
• Device Lot Number: CMBT0082
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/18/2019
• Patient Sequence Number: 1