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

Model Number	425-2515X
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for inspection/evaluation.The investigation is currently underway.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 information indicated that model 425-2515x pta balloon dilatation catheter allegedly ruptured.This report was received from one source.The patient's age, weight, and gender were not provided.There was no reported patient injury.
Additional Manufacturer Narrative
H10: one device was returned for the reported malfunction.The lot number was provided and a lot history review was performed.The investigation is inconclusive for the reported balloon rupture.However, the investigation confirmed for leak/splash and device-device incompatibility.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 information indicated that model 425-2515x pta balloon dilatation catheter allegedly ruptured, leaked, and experienced device-device incompatibility.This report was received from one source.The patient's age, weight, and gender were not provided.There was no reported patient injury.

• 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: 9182921
• Report Number: 9616666-2019-00115
• Device Sequence Number: 16798063
• 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): 01/06/2020

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: 425-2515X
• Device Catalogue Number: 425-2515X
• Device Lot Number: CMCY0215
• 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: 01/06/2020
• Patient Sequence Number: 1