MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. SLEEK RX PTA CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	425-3012X
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 one sample belonging to the single malfunction is expected to be returned to bd for evaluation.The company is still investigating the issue at this time.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 425-3012x pta balloon dilatation catheter allegedly experienced material rupture.This information was received from one source.The one malfunction involved a single patient with no patient consequences.The age, weight, and gender of the patient was not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 425-3012x pta balloon dilatation catheter allegedly experienced material rupture.This information was received from one source.The one malfunction involved a single patient with no patient consequences.The age, weight, and gender of the patient was not provided.
Additional Manufacturer Narrative
H10: the lot number was provided for the one reported malfunction; therefore, a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation and confirmed for material rupture and material deformation.Therefore, the reported event was confirmed.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.

• Brand Name: SLEEK RX 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: 9182957
• Report Number: 9616666-2019-00118
• Device Sequence Number: 2657528
• Product Code: LIT
• UDI-Device Identifier: 00801741132452
• UDI-Public: (01)00801741132452
• 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): 01/07/2020

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: 425-3012X
• Device Catalogue Number: 425-3012X
• Device Lot Number: 50141099
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 01/07/2020
• Patient Sequence Number: 1