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

Model Number	24634
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the blade detached and required additional intervention.The target lesion area was located in the left pulmonary artery.A 8.00mm/2.0cm/135cm peripheral cutting balloon was selected for use.During the procedure, the cutting balloon was being removed and resistance was noted.However, it was noted that only 3 blades were seen on the balloon.The sheath was exchanged and the blade was not seen.Subsequently, the physician confirmed that there was a blade missing by opening another peripheral cuttting balloon for comparison.The detached blade was located in the lung by fluoroscopy.Snare was performed to retrieve the blade and was successful.The patient is stable.No complications reported.
Event or Problem Description
It was reported that the blade detached and required additional intervention.The target lesion area was located in the left pulmonary artery.A 8.00mm/2.0cm/135cm peripheral cutting balloon was selected for use.During the procedure, the cutting balloon was being removed and resistance was noted.However, it was noted that only 3 blades were seen on the balloon.The sheath was exchanged and the blade was not seen.Subsequently, the physician confirmed that there was a blade missing by opening another peripheral cuttting balloon for comparison.The detached blade was located in the lung by fluoroscopy.Snare was performed to retrieved the blade and was successful.The patient is stable.No complications reported.It was further reported that the procedure was performed to treat pulmonary stenosis in the pulmonary valves.

• 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: 10860900
• Report Number: 2134265-2020-15946
• Device Sequence Number: 16774717
• Product Code: PNO
• UDI-Device Identifier: 08714729813781
• UDI-Public: 08714729813781
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/14/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/17/2021
• Device Model Number: 24634
• Device Catalogue Number: 24634
• Device Lot Number: 0023971103
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 12/15/2020
• 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: Required Intervention
• Patient Age: 3 YR