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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVASIVE/BOSTON SCIENTIFIC CORP.GEMINI PAIRED WIRE HELICAL BASKETSTONE RETRIEVAL BASKETS

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MICROVASIVE/BOSTON SCIENTIFIC CORP. GEMINI PAIRED WIRE HELICAL BASKET STONE RETRIEVAL BASKETS   Back to Search Results
Catalog Number 330-108
Event Date 12/11/1997
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

It was reported this retrieval was used to successfully engage a stone from the pt's ureter. A laser fiber was then advanced to break up the stone. Upon removal of the basket resistance was encountered. The device was removed and it was noted at that time, the distal portion of the retrieval basket remained in the pt. Surgical retrieval of the basked was successful. The pt's condition is good. The device was received and evaluated by this mfr. A portion of the basked remained attached to the device and a small section of a basket was returned in a specimen container. The section of basket attached to the device had all four pairs of wire broken in a staggered manner. None of the pairs were broken in the same location. The distal section of the basket received in the specimen cup was broken in the same manner. The broken edges of two sets of paired wires were blackened, indicating possible contact with a laser fiber. One set of wires was bent severely, as if it had been forced back and forth in an attempt to break the wire, and the remaining set appears to have been cut. Although the medwatch report received from the user facility indicated a laparotomy was performed, co's f/u revealed the procedure was a cystoscope stone retrieval/laser lithotripsy. Further info as well as the engineering evaluation indicated the basket wires appears to have been melted from the laser fiber. Co believes direct fire of the laser on the basket wires may have contributed to this and do not attribute it to the device. The directions for use state: "the helical basket is designed to be used through the small working channel of an endoscope, such as a ureteroscope or nephroscope during the procedure. This device must not come in contact with any electrified instrument. This device should not be directly fired upon by a pulsed dye laser. If resistance is encountered while attempting to withdraw the basket into the sheath or the sheath through the scope, do not exert excessive force. ".

 
Manufacturer Narrative

A1, a2, a3, a4, b6, b7, d10 - unk/no info available from user facility. F11. Date mfr forwarded report to fda. Info supplied in section f was completed by the mfr based on info obtained from the user facility. Any info not included in this section was na at the time of submission of this medwatch report to the fda.

 
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Brand NameGEMINI PAIRED WIRE HELICAL BASKET
Type of DeviceSTONE RETRIEVAL BASKETS
Baseline Brand NameGEMINI PAIRED WIRE HELICAL BASKET
Baseline Generic NameSTONE RETRIEVAL BASKETS
Baseline Catalogue Number330-108
Manufacturer (Section F)
MICROVASIVE/BOSTON SCIENTIFIC CORP.
480 pleasant st.
watertown MA 02172
Manufacturer (Section D)
MICROVASIVE UROLOGY A DIVISION OF BOSTON SCIENTIFIC CORP.
780 brookside drive
spencer IN 47460
Device Event Key138709
MDR Report Key142213
Event Key133548
Report Number6000043-1998-00005
Device Sequence Number1
Product CodeFFL
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 12/16/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/08/1998
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date10/02/2001
Device Catalogue Number330-108
Device LOT Number702994
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/30/1997
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/08/1998
Device Agena
Event Location Hospital
Date Manufacturer Received12/16/1997
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/01/1997
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 01/08/1998 Patient Sequence Number: 1
#TreatmentTreatment Date
UNK
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