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MAUDE MDR 1556835

MDR report key
1556835
Report number
1219038-2009-00001
Event key
0
Event type
3
Date of event
2009-10-27
Date received
2009-12-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
278 WORCESTER ST SOUTHBRIDGE MA 01550 US
Phone
508-508-5087
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CLINICAL INSTRUMENTS EMBOLECTOMY CATHETEREMBOLECTOMY CATHETERCLINICAL INSTRUMENTS INTERNATIONAL, INC.DXE5F2L 40CM5F2L 40 CM010809095R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-12-0801. R

Event Narratives#

D

Patient 1

ON 11/13/2009, OF TWO CUSTOMER COMPLAINTS INVOLVING CATHETERS MANUFACTURED BY CLINICAL AND SOLD, WHO REPACKAGED THE CATHETERS AND SOLD THEM TO THEIR CUSTOMERS. DURING A DECLOT PROCEDURE, THE BALLOON ON THE CATHETER SEPARATED FROM THE CATHETER AND BECAME LODGED IN THE PT'S GRAFT. THE BALLOON WAS REMOVED BY THE PHYSICIAN WITH A SNARE. SEE MDR 1219038-2009-00002 FOR THE SECOND EVENT.

N

Patient 1

CATHETER NOT RETURNED TO CLINICAL INSTRUMENTS INTL. ADD'L LOT #: 012009096, DATE OF MFR: 01/20/2009, EXPIRATION DATE: 01/19/2012. ADD'L LOT #: 013009105, DATE OF MFR: 01/30/2009, EXPIRATION DATE: 01/29/2012. ADD'L LOT #: 021209120, DATE OF MFR: 02/12/2009, EXPIRATION DATE: 02/11/2012. ADD'L LOT #: 051409164, DATE OF MFR: 05/14/2009, EXPIRATION DATE: 05/13/2012. ADD'L LOT #: 051909169, DATE OF MFR: 05/19/2009, EXPIRATION DATE: 05/18/2012. NOTE: ARROW INTERNATIONAL INFORMED CLINICAL INSTRUMENTS THAT THE CATHETER INVOLVED IN THIS EVENT CAME FROM ONE OF THE ABOVE CLINICAL INSTRUMENT LOT #S.