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U.S. Department of Health and Human Services

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

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CLEARSTREAM TECHNOLOGIES LTD. BANTAM OTW PTA CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number 48510025
Device Problems Stretched; Detachment of Device or device Component
Event Date 09/25/2019
Event Type  Injury  
Manufacturer Narrative

Photos were provided to the manufacturer. The lot number for the device was provided. The device history records are currently under review. The device is not available for return. The investigation is currently underway. The catalog number identified in section has not been cleared in the u. S. But, it is similar to the savvy long pta balloon dilatation catheter products that are cleared in the us. The 510k number and pro code for the savvy long pta balloon dilatation catheter products are identified.

 
Event Description

It was reported that during treatment of the anterior tibial artery (ata), the pta balloon was inflated at 14 atm for 30 seconds and deflated; however, during withdrawal, the balloon allegedly detached from the catheter. As a result, a second intervention required an additional pta catheter to push the balloon towards the ankle for surgical extraction. Hospitalization was prolonged four days due to the event and the patient is in stable condition.

 
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Brand NameBANTAM OTW PTA CATHETER
Type of DevicePTA 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
judith ludwig
1415 w. 3rd street
tempe , AZ 85281
4803032689
MDR Report Key9253149
Report Number9616666-2019-00139
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/18/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/29/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number48510025
Device LOT NumberCMDQ0069
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/25/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/12/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/06/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/29/2019 Patient Sequence Number: 1
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