MAUDE Adverse Event Report: SPECTRANETICS ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX); CATHETER, PTCA, CUTTING/SCORING

Model Number	2200-3510
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's dob, age at time of event, or weight is unknown.Attempts to obtain the information has not been successful.Although the separated portion of the shaft occurred outside of the body, this is being reported as a conservative measure.Recurrence of the shaft separation could result in vessel obstruction, possible myocardial infarction, or may require surgical intervention.No patient injury.Patient information regarding relevant tests/laboratory data or medical history are unknown.Attempts to obtain the information has not been successful.The angiosculpt device was returned in two pieces.The shaft separated approximately 7.5¿ from the hub and the rx port was lacerated.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.
Event or Problem Description
During delivery to the lesion, prior to balloon inflation, the angiosculpt device separated at the proximal shaft (outside of body).The balloon was able to be removed with no patient injury.
Additional Manufacturer Narrative
Additional information received on jan 4, 2019 is listed.The patient's dob, age at time of event, or weight remains unknown.The facility declined to provide this information.

• Brand Name: ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)
• Common Device Name: CATHETER, PTCA, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• MDR Report Key: 8206988
• Report Number: 3005462046-2018-00028
• Device Sequence Number: 1901155
• Product Code: NWX
• UDI-Device Identifier: 00813132021238
• UDI-Public: 00813132021238
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P050018
• 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): 12/06/2018
• 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: 04/11/2020
• Device Model Number: 2200-3510
• Device Catalogue Number: 2200-3510
• Device Lot Number: G17040027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 12/31/2018
• Supplement Report FDA Received Date: 01/15/2019
• 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: ASAHI: SION BLUE GUIDE WIRE, 0.014"; MEDTRONIC: GUIDE CATHETER 6F; ST. JUDE MEDICAL: INTRODUCER SHEATH 6F; UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: GUIDE WIRE; UNK MFG AND SIZE: INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 01/01/2005