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

Model Number	2200-3515
Medical Device Problem Codes	Deflation Problem (1149); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's dob, age at time of event, or weight is unknown.This information was not available from the facility.The angiosculpt shaft ruptured after multiple inflation above the rated burst pressure; resulting in the balloon unable to fully deflate.Recurrence of the balloon deflation issue could result in a vessel dissection, vessel obstruction, myocardial infarction, or may require surgical intervention.The angiosculpt device was returned for investigation.Visual examination found an inverted balloon at the distal end and a damaged proximal bond.A ruptured distal shaft was observed approximately 0.5 cm proximal to the proximal bond.Under microscopic inspection, a longitudinal shaft tear was noted.In addition, the distal shaft had two bubbles (expanded but not ruptured) proximal to the longitudinal tear.During functional testing, the balloon was pressurized, but unable to inflate due to the ruptured shaft.The report of unable to deflate could not be replicated due to nature of the returned device.The angiosculpt device was inflated multiple times above the rated burst pressure of 16 atm.It is probable, the over inflation of the device induced stress on the shaft material, resulting in the ruptured shaft.The ifu warns to not exceed the rated burst pressure as indicated on the product label.
Event or Problem Description
The angiosculpt device was inflated/deflated multiple times at 18 atm.During the last inflation, the shaft seemed to have detached from the catheter and was unable to fully deflate.The device was removed intact with no resistance and no intervention required.

• 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: 8155455
• Report Number: 3005462046-2018-00026
• Device Sequence Number: 19265635
• Product Code: NWX
• UDI-Device Identifier: 00813132021245
• UDI-Public: 00813132021245
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2018
• 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: 04/30/2021
• Device Model Number: 2200-3515
• Device Catalogue Number: 2200-3515
• Device Lot Number: G18040040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 12/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 01/01/2005