MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Model Number	24630
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528)
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 device was returned for analysis.The recommended sheath size for this device is a 7fr introducer sheath.The returned device was received together with customers introducer sheath.The customers sheath was noted to have a split beginning at the distal tip and extending proximally for approximately 5mm.On analysis, the investigator was unable to carry out device to device testing due to the severe damage to the returned pcb2cm device.A visual and microscopic examination identified that the balloon had been inflated.A complete circumferential tear of the balloon material was identified located approximately 20mm proximal of the tip.The distal section of the balloon material including all the blades was completely detached from the device at the distal balloon bond.The distal section of balloon material including all blades was not returned for analysis.The proximal section of balloon material was completely detached from the shaft at the proximal balloon bond.No issues were identified with the balloon material that may have contributed to the complaint incident.All blades were completely detached from the device.None of the blades were returned for analysis.A microscopic examination found no issues with the tip or markerbands of the device.A visual and tactile examination found the shaft to be severely accordioned at several locations along the length of the shaft.The shaft was also noted to be kinked at more than one location.No other issues were identified during the product analysis.
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: 2CM PERIPHERAL CUTTING BALLOON
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8703910
• Report Number: 2134265-2019-07024
• Device Sequence Number: 2073457
• Product Code: PNO
• UDI-Device Identifier: 08714729813804
• UDI-Public: 08714729813804
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K151253
• 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): 08/14/2019

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: 08/02/2019
• Device Model Number: 24630
• Device Catalogue Number: 24630
• Device Lot Number: 0020961289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1