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

Model Number	436-2512L
Medical Device Problem Codes	Material Rupture (1546); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the evaluation confirmed material rupture and material deformation.Based upon the available information, a 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 436-2512l pta balloon dilatation catheter allegedly experienced material rupture and material deformation.This information was received from one source.This malfunction involved one patient with no patient consequence.The age, weight, and gender of the patient was not provided.

• 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: 9174948
• Report Number: 9616666-2019-00106
• Device Sequence Number: 19540745
• Product Code: LIT
• UDI-Device Identifier: 00801741132773
• UDI-Public: (01)00801741132773
• 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): 10/10/2019

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: 436-2512L
• Device Catalogue Number: 436-2512L
• Device Lot Number: 50136440
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/10/2019
• Patient Sequence Number: 1