MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PLATINUM PLUS; WIRE, GUIDE, CATHETER

Model Number	39935
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon became stuck on the guide wire.The target lesion was located in the innominate vein.A 3 018/180 platinum plus guidewire an a 2cm peripheral cutting balloon (pcb) were used in a procedure.When the physician pulled the pbc out of the sheath, the tip of the sheath became damaged and the balloon was stuck.The physician pulled everything out and managed to keep the wire access, but the physician had to cut the wire because it became stuck with the balloon.The procedure was completed without any patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr.: the guidewire returned with the proximal section stuck in a pcb 2cm device.Moreover, the device returned detached in three sections including the section stuck on the pcb 2cm device.Additionally, the guidewire was returned peeled at the distal section and with the spring tip kinked.The outer diameter dimensions were found within specification.
Event or Problem Description
It was reported that balloon became stuck on the guide wire.The target lesion was located in the innominate vein.A 3 018/180 platinum plus guidewire an a 2cm peripheral cutting balloon (pcb) were used in a procedure.When the physician pulled the pbc out of the sheath, the tip of the sheath became damaged and the balloon was stuck.The physician pulled everything out and managed to keep the wire access, but the physician had to cut the wire because it became stuck with the balloon.The procedure was completed without any patient complications.

• Brand Name: PLATINUM PLUS
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8703897
• Report Number: 2134265-2019-07004
• Device Sequence Number: 16740746
• Product Code: DQX
• UDI-Device Identifier: 08714729114567
• UDI-Public: 08714729114567
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K935997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2019

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: 08/30/2021
• Device Model Number: 39935
• Device Catalogue Number: 39935
• Device Lot Number: 0022593559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2019
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1