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

Model Number	AB35SX060060135
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's age at time of event or dob, gender, and weight are unknown.This information was not available from the facility.During inflation, the balloon ruptured.Recurrence of this malfunction could result in a prolonged intervention.No patient injury reported.This mdr is being reported per fda mandate.  patient information regarding relevant tests/laboratory data or medical history are unknown.This information was not available from the facility.The stellarex device is in transit to manufacturer's' facility.Device evaluation will be performed upon arrival and a supplemental mdr to follow.Per the ifu, balloon rupture is listed as a potential complication of the peripheral balloon.
Event or Problem Description
The stellarex device was used in a severely calcified and slightly tortuous mid sfa.During inflation at nominal pressure for thirty seconds, the balloon ruptured.No patient injury reported.
Additional Manufacturer Narrative
Block d10/g4: the stellarex device was returned for evaluation on 07/01/2020.Block h3: the stellarex device was returned for evaluation.Visual examination found presence of blood inside the balloon.During functional testing, the device was pressurized multiple times, but unable to inflate.To determine a balloon leak, the balloon portion was severed from the catheter shaft.Using a needle and syringe for inflation, the balloon was pressurized to nominal (8 atm) with no leaks noted.Although, there was no leak on the balloon, the reported complaint was confirmed conservatively, based on the presence of blood inside the balloon.H3 other text: placeholder.

• Brand Name: STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON
• Common Device Name: DCB PTA CATHETER
• Manufacturer (Section D): SPECTRANETICS; 6531 dumbarton circle; fremont CA 94555
• MDR Report Key: 10215793
• Report Number: 3009784280-2020-00200
• Device Sequence Number: 2404624
• Product Code: ONU
• UDI-Device Identifier: 00813132024291
• UDI-Public: 00813132024291
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P160049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2020
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/02/2020
• Device Model Number: AB35SX060060135
• Device Catalogue Number: AB35SX060060135
• Device Lot Number: FVY18K12A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO: 6F INTRODUCER SHEATH.; UNK MFG AND SIZE: GUIDE WIRE.
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 01/01/2005