MAUDE Adverse Event Report: SPECTRANETICS ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW); CATHETER, PERCUTANEOUS, CUTTING/SCORING

Model Number	2237-50100
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient's dob, age at time of event, gender, or weight is unknown.This information was not available from the facility.The user did not fully deflate the balloon and during withdrawal, it got caught in the undersized introducer sheath.Additional intervention was performed for device removal, thus resulting in a prolonged procedure.Patient information regarding relevant tests/laboratory data or medical history are unknown.The information was not available from the facility.The angiosculpt device was discarded, thus no product investigation was performed.Based on the complaint details, the user failed to follow instructions.The ifu states to confirm the balloon is fully deflated prior to removal.In addition, the device was used off-label by using an undersized introducer sheath (5f).The product label indicates the angiosculpt device is compatible with a 6f introducer sheath.
Event or Problem Description
The physician inserted a 5f introducer sheath in the patient¿s left groin and directed towards the right distal sfa to treat a stenotic calcified lesion.Then an angiosculpt device was inserted through the introducer sheath and the balloon was inflated and deflated with no issues.During withdrawal, the angiosculpt got caught in the introducer sheath and could not be removed. the physician cut the proximal shaft and introducer sheath together for removal, but decided to pull the angiosculpt, introducer sheath, and guide wire as a system.Completion of the angiogram confirmed no retained parts of the angiosculpt or introducer sheath was left in the patient.Upon removal, the balloon appeared to not have fully deflated and contrast was noted inside the balloon.No patient injury reported.
Additional Manufacturer Narrative
Block a2/a3: patient's age and gender were obtained from the user facility report # (b)(4).H3 other text : placeholder.

• Brand Name: ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
• Common Device Name: CATHETER, PERCUTANEOUS, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• MDR Report Key: 10054330
• Report Number: 3005462046-2020-00007
• Device Sequence Number: 14165340
• Product Code: PNO
• UDI-Device Identifier: 00813132022839
• UDI-Public: 00813132022839
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K142983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2020
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/24/2021
• Device Model Number: 2237-50100
• Device Catalogue Number: 2237-50100
• Device Lot Number: G19100042
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 05/13/2020
• Supplement Report FDA Received Date: 05/29/2020
• 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: BOSTON SCIENTIFIC: 0.014" PT GRAPHIX GUIDE WIRE; COOK: 5F INTRODUCER SHEATH; COOK: 7F ANSEL GUIDE CATHETER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Date Report Sent to FDA: 01/01/2005