MAUDE Adverse Event Report: SPECTRANETICS STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON; DCB PTA CATHETER

Model Number AB35SX050120135

Device Problems Deflation Problem (1149); Inflation Problem (1310)

Patient Problem No Code Available (3191)

Event Date 11/15/2017

Event Type  Injury  

Manufacturer Narrative

The patient's age at time of event or dob and weight are unknown.This information was not available from the facility.The stellarex device was unable to deflate.Additional intervention was required to remove from the patient, thus resulted in a prolonged procedure.Patient information regarding relevant tests or laboratory data is unknown.This information was not available from the facility.Availability to enter this information is still work in progress at (b)(4), thus the drug information is noted below: stellarex 0.035 otw drug-coated angioplasty balloon, paclitaxel drug, 3880 ug.Therapy date: (b)(6) 2017.The stellarex¿ 0.035¿ otw drug-coated angioplasty balloon is indicated for percutaneous transluminal angioplasty (pta), after appropriate vessel preparation of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.Lot #: fhs17e05a.Expiration date: 06/01/2018.(b)(4).The stellarex device was returned for evaluation.Visual examination found no unusual characteristics of the device.The proximal balloon showed no signs of necking or bunching.There were no signs of a balloon twist and no deformation was noted on the shaft.During functional testing, the balloon was inflated, but would not hold pressure due to a pinhole leak on the proximal end of the balloon.Per the ifu, ''device embolism'' is listed as a potential complication/ adverse event of the procedure.In addition, ''failure of the balloon to perform as intended'' is listed as a potential complication of the peripheral balloon characterization.

Event Description

As the indeflator was increasing in atmospheres, the balloon would not inflate.As the physician decreased the atmospheres, the balloon began to inflate.The pressure was increased by 2 atmospheres to nominal and held for 2 minutes.During deflation, the balloon would not deflate.After unsuccessfully using a 20cc and 60cc syringe to deflate the balloon, under ultrasound, a needle was used to stick the balloon and safely removed it.The physician then took a run with contrast under fluoroscopy and the image looked great.

• Brand Name: STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON
• Type of Device: DCB PTA CATHETER
• Manufacturer (Section D): SPECTRANETICS; fremont CA
• Manufacturer (Section G): SPECTRANETICS; 6531 dumbarton circle; fremont CA 94555
• Manufacturer Contact: florie cazem ; 5055 brandin court; fremont, CA 94538 ; 510933-792
• MDR Report Key: 7102718
• MDR Text Key: 94357478
• Report Number: 3009784280-2017-00090
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2018
• Device Model Number: AB35SX050120135
• Device Catalogue Number: AB35SX050120135
• Device Lot Number: FHS17E05A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention