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

Model Number	425-2012X
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The one device belonging to the one 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.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 425-2012x pta balloon dilatation catheter allegedly experienced material rupture.This information was received from one source.This malfunction involved one patient with no patient consequences.The patient¿s weight, age, and gender were not provided.
Additional Manufacturer Narrative
H10: a manufacturing review could not be carried out as there was no lot number provided.The device has been returned for evaluation; the evaluation confirmed material rupture.Based upon the available information, a definitive root cause 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 425-2012x pta balloon dilatation catheter allegedly experienced material rupture.This information was received from one source.This malfunction involved one patient with no patient consequences.The patient¿s weight, age, and gender were not provided.

• 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: 9182877
• Report Number: 9616666-2019-00110
• Device Sequence Number: 2693079
• Product Code: LIT
• UDI-Device Identifier: 00801741132261
• UDI-Public: (01)00801741132261
• 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): 01/03/2020

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: 425-2012X
• Device Catalogue Number: 425-2012X
• Device Lot Number: UNKNOWN
• 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: 01/03/2020
• Patient Sequence Number: 1