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

Model Number	436-2515X
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
As the lot number for the device was provided, a lot history review will be performed.For the reported malfunction, the return of the sample is pending.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction.A review of the malfunction indicated that model 436-2515x pta balloon dilatation catheter was allegedly experienced material rupture.This report was received from one source.The event involved a patient with no known impact to the patient.The (b)(6) year old male patient was (b)(6) kgs.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a lot history review will be performed.The sample was returned to the manufacturer for evaluation.Investigation of the returned sample confirmed material rupture and kink.Based on the available information, a definitive root cause of the event could not be determined.The device was labeled for single use.H11:b5, h6 (method, result, conclusion).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
This report summarizes one malfunction.A review of the malfunction indicated that model 436-2515x pta balloon dilatation catheter allegedly experienced material rupture and material deformation.This report was received from one source.The event involved a patient with no known impact to the patient.The 57 year old male patient was 72 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: 10283225
• Report Number: 9616666-2020-00069
• Device Sequence Number: 13625539
• Product Code: LIT
• UDI-Device Identifier: 00801741132827
• UDI-Public: (01)00801741132827
• 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): 10/13/2020

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: 436-2515X
• Device Catalogue Number: 436-2515X
• Device Lot Number: CMDS0501
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 10/13/2020
• Patient Sequence Number: 1