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

Model Number	425-2515X
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for the one reported event.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 event.A review of the events indicated that model 425-2515x pta dilatation catheter allegedly had a shaft break and material deformation.This report was received from one sources.The device was used in the patient, with no patient injury reported.The patient's age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: the device was returned for the one reported event.The result of the investigation is confirmed for the material deformation issue reported, although the device was returned in poor condition.The hub and a partial section of the shaft were not returned which identifies a break.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 event.A review of the events indicated that model 425-2515x pta dilatation catheter allegedly had a shaft break and material deformation.This report was received from one sources.The device was used in the patient, with no patient injury reported.The patient's age, weight, and gender were not provided.

• Brand Name: SLEEK PTA DILATATION CATHETER
• Common Device Name: PTA DILATATION CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• MDR Report Key: 8533459
• Report Number: 9616666-2019-00048
• Device Sequence Number: 19207838
• Product Code: LIT
• UDI-Device Identifier: 00801741132384
• UDI-Public: (01)00801741132384
• 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): 07/23/2019

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: 425-2515X
• Device Catalogue Number: 425-2515X
• Device Lot Number: CMBW0442
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1