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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPECTRANETICS STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON; DCB PTA CATHETER
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SPECTRANETICS STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON; DCB PTA CATHETER Back to Search Results
Model Number A35SX060080080
Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528)
Patient Problems Ischemia (1942); Peripheral Vascular Disease (2002)
Event Date 04/24/2018
Event Type  Injury  
Manufacturer Narrative
The stellarex catheter was returned intact within a 6f introducer sheath and the balloon protector sheath was pulled back near the strain relief.Visual inspection found a bunched balloon that had a proximal radial tear and would not allow the catheter to be removed from the introducer sheath.The mono lumen was stretched and both marker bands were present.Measurement of the balloon length met specification, which indicates there are no missing fragments.Per the ifu, embolism/device embolism is listed as a potential complication/adverse event of the procedure.
 
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Brand Name
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON
Type of Device
DCB PTA CATHETER
Manufacturer (Section D)
SPECTRANETICS
6531 dumbarton circle
fremont CA
MDR Report Key7532111
MDR Text Key311304059
Report Number3009784280-2018-00052
Device Sequence Number1
Product Code ONU
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/01/2005,04/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/11/2019
Device Model NumberA35SX060080080
Device Catalogue NumberA35SX060080080
Device Lot NumberFCS17L16A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/22/2018
Supplement Dates Manufacturer Received05/29/2018
Supplement Dates FDA Received06/15/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number0
Treatment
ABBOTT: 0.035" GUIDE WIRE; TERUMO: 6F INTRODUCER SHEATH
Patient Outcome(s) Required Intervention;
Patient Age79 YR
Patient Weight72
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