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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 A35SX060120135
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 12/16/2016
Event Type  Death  
Manufacturer Narrative
The patient's cause of death was unrelated to the study device or procedure.This is being reported as a follow-up to the clinical registry.Cross reference mfr report numbers: 3009784280-2019-00752.Patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.Report source: foreign: (b)(6) study name: (b)(6): patient id # (b)(6).Pma/510k: pma number is not applicable.The device is a commercial product with a ce mark that was used as part of a clinical registry.During the index procedure, the product worked as intended and the device was discarded, thus no product evaluation was required.Per the ifu, death is listed as a potential complications/adverse events.
 
Event Description
It was reported through a clinical registry that during the index procedure on (b)(6) 2016, two stellarex catheters were used to treat the target lesion of the left mid sfa.Approximately 26 months post index procedure, the patient expired due to colon cancer and liver metastases on (b)(6) 2019.
 
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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 94555
Manufacturer (Section G)
SPECTRANETICS
6531 dumbarton circle
fremont CA 94555
Manufacturer Contact
sallie heraldo
5055 brandin court
fremont, CA 94538
510933-798
MDR Report Key9526947
MDR Text Key172925279
Report Number3009784280-2019-00751
Device Sequence Number1
Product Code ONU
Combination Product (y/n)Y
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,study
Reporter Occupation Physician
Type of Report Initial
Report Date 01/01/2005,12/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Device Expiration Date07/29/2018
Device Model NumberA35SX060120135
Device Catalogue NumberA35SX060120135
Device Lot NumberFYZ16G20B
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Initial Date Manufacturer Received 12/18/2019
Initial Date FDA Received12/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age70 YR
Patient Weight81
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