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

Catalog Number UNKNOWN BANTAM

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Material Deformation (2976); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2021

Event Type  malfunction  

Event Description

It was identified as part of a customer survey that post bantam pta balloon catheter use on over four thousand nine hundred and ninety patients, eight in ten cases were successful, two percentage had crush and migration after crush. It was unknown whether any re-intervention was performed. The current status of the patients was unknown.

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow-up report will be submitted as applicable. The catalog number identified has not been cleared in the us but is similar to the savvy long pta dilatation catheter products that are cleared in the us. The pro code and 510 k number for the savvy long pta dilatation catheter products are identified in common device name and pma/510k. Device not returned.

• 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
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13658339
• MDR Text Key: 286562808
• Report Number: 9616666-2022-00033
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K072947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UNKNOWN BANTAM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial