MAUDE Adverse Event Report: SPECTRANETICS STELLAREX 0.014 OTW DRUG-COATED ANGIOPLASTY BALLOON; DCB PTA CATHETER

Model Number A14SX030150150T

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling (2091)

Event Date 04/03/2019

Event Type  Injury  

Manufacturer Narrative

The patient experienced swelling and pain at the puncture site.This is being reported as part of a clinical study.Report source: foreign- (b)(6).Pma number is not applicable.The device is ce marked that was used as part of a clinical study under an ide.During the index procedure, the product worked as intended, thus no returned product evaluation was required.Per the ifu, pain at the insertion site is listed as a potential complications/adverse events.

Event Description

It was reported through a clinical study that during the index procedure on (b)(6) 2019, a stellarex catheter was used to treat the target lesion of the left distal popliteal artery.Seven days post index procedure, the patient was in the outpatient clinic due to swelling and pain in the right groin from the procedure.The physician excluded pseudoaneurysm and re-bleeding, thus recommended protection of the puncture site and for patient to return in case the condition of the puncture site deteriorates.The physician indicated this was related to the procedure and unlikely related to the study device.

Manufacturer Narrative

Block g5: pma number is not applicable.Upon further review, it was identified that this complaint was not required to be reported through this process.This is a non-commercial product that is captured under the ide for the illuminate btk clinical study.H3 other text : placeholder.

• Brand Name: STELLAREX 0.014 OTW DRUG-COATED ANGIOPLASTY BALLOON
• Type of Device: DCB PTA CATHETER
• Manufacturer (Section D): SPECTRANETICS; 6531 dumbarton circle; fremont CA 94555
• MDR Report Key: 8574297
• MDR Text Key: 143853467
• Report Number: 3009784280-2019-00154
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,04/10/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2018
• Device Model Number: A14SX030150150T
• Device Catalogue Number: A14SX030150150T
• Device Lot Number: CRX17K11A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 05/02/2019
• Supplement Dates Manufacturer Received: 07/11/2019
• Supplement Dates FDA Received: 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: GUIDE WIRE; UNK MFG AND SIZE: INTRODUCER SHEATH; UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: GUIDE WIRE; UNK MFG AND SIZE: INTRODUCER SHEATH
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR
• Patient Weight: 100