MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. ULTRAVERSE 018 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	U8130630
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 lot number was provided, therefore a lot history review was performed.The sample was not returned for evaluation and the investigation is inconclusive for balloon rupture.The definitive root cause could not be determined based upon available information.The device was labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model u8130630 pta balloon dilatation catheter allegedly experienced balloon rupture.This information was received from one source.This malfunction involved one patient with no consequences.The (b)(6) year old male weighs (b)(6) lbs.

• Brand Name: ULTRAVERSE 018 PTA DILATATION 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: 10734781
• Report Number: 2020394-2020-06065
• Device Sequence Number: 13981582
• Product Code: LIT
• UDI-Device Identifier: 00801741064654
• UDI-Public: (01)00801741064654
• 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
• Report Date (Section B): 10/26/2020

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: U8130630
• Device Catalogue Number: U8130630
• Device Lot Number: CMDW0014
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/26/2020
• Patient Sequence Number: 1