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

Catalog Number 48522020

Device Problems Break (1069); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 48522020 pta catheter allegedly experienced breaking and material twisting.This information was received from one source.The malfunction involved a patient with no consequences.The patient was (b)(6) years of age and weight was not provided.The reported patient was female.

Manufacturer Narrative

H.10.For the reported event, lot number was provided, and lot history review.The sample was returned for evaluation.The investigation is unconfirmed for the reported catheter bend and detachment issues.A root cause has not been determined.The device was labeled for single use.H11: b5: event; h6 (device code + description 1), h6 (results, conclusion).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 Description

This report summarizes one malfunction.A review of the reported information indicated that model: 48522020 pta catheter allegedly experienced breaking and material twisting.This information was received from one source.The malfunction involved a patient with no consequences.The female patient was 58 years of age, and weight was not provided.

• Brand Name: BANTAM OTW 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: 8785305
• MDR Text Key: 150851680
• Report Number: 9616666-2019-00082
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 05391515540620
• UDI-Public: (01)05391515540620
• 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: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48522020
• Device Lot Number: CMBU0038
• Date Manufacturer Received: 09/30/2019
• Patient Sequence Number: 1