MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. BANTAM PTW PTA CATHETER; PTA BALLOON DILATATION CATHETER

Catalog Number 48506050

Device Problems Leak/Splash (1354); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified in section has not been cleared in the us, but is similar to the bantam otw pta catheter products that are cleared in the us.The pro code for the bantam otw pta catheter products is identified.As the lot number was provided, a lot history review will be performed.The sample was not returned for evaluation, therefore the investigation is inconclusive for the alleged leak and material rupture issues.The root cause could not be determined.The device was labeled for single use.

Event Description

This report summarizes one malfunction.A review of reported information indicates that model 48506050, pta balloon dilatation catheter, allaged experienced leak and material rupture.This information was recieved from a single source.This malfunction involved a (b)(6) female patient with no consequences.The patient's weight was not provided.

Event Description

This report summarizes one malfunction.A review of reported information indicates that model 48506050, pta balloon dilatation catheter, alleged experienced leak and material rupture.This information was received from a single source.This malfunction involved a 70 year old female patient with no consequences.The patient's weight was not provided.

Manufacturer Narrative

H10: of the reported malfunction, the file was reassessed for reportability and determined to be no longer reportable.The catalog number identified in section d4 has not been cleared in the us, but is similar to the bantam otw pta catheter products that are cleared in the us.The pro code for the bantam otw pta catheter products is identified in d2.As the lot number was provided, a lot history review will be performed.The sample was not returned for evaluation, therefore the investigation is inconclusive for the alleged leak and material rupture issues.The root cause could not be determined.The device was 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.

• Brand Name: BANTAM PTW PTA CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• MDR Report Key: 9583858
• MDR Text Key: 195308515
• Report Number: 9616666-2020-00008
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48506050
• Device Lot Number: CMDP0305
• Date Manufacturer Received: 03/25/2020
• Patient Sequence Number: 1