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

Model Number	426-2022X
Medical Device Problem Codes	Material Rupture (1546); Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided, therefore a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event 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 426-2022x pta balloon dilatation catheter allegedly experienced rupture and detachment.This report was received from one source.This malfunction involved a patient with no consequences.The patient's age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: the lot number was provided for the reported malfunction; therefore, a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation.Therefore, the investigation is unconfirmed for the reported rupture and detachment, additionally stretch is identified in the evaluation.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.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 reported information indicated that model 426-2022x pta balloon dilatation catheter allegedly experienced rupture, detachment and streched.This report was received from one source.This malfunction involved a patient with no consequences.The patient's age, weight, and gender were not provided.

• Brand Name: SLEEK 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: 10715048
• Report Number: 9616666-2020-00094
• Device Sequence Number: 3281733
• Product Code: DQY
• UDI-Device Identifier: 00801741133626
• UDI-Public: (01)00801741133626
• 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): 01/13/2021

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: 426-2022X
• Device Catalogue Number: 426-2022X
• Device Lot Number: CMCV0177
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 01/13/2021
• Patient Sequence Number: 1