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

Model Number	24630
Medical Device Problem Codes	Difficult to Remove (1528); Device-Device Incompatibility (2919); Difficult to Advance (2920)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulties were encountered and the balloon cut the sheath.The target lesion was located in the left brachial access.A 6.00mm/2.0cm/90cm peripheral cutting balloon (pcb) was selected for use.During removal of the pcb, resistance was felt upon entering the sheath.The device was removed and continued to treat the lesion with a drug coated balloon.However, some bleeding was noticed at the sheath site and after examining the sheath it was noticed that it had been compromised by a horizontal cut.No patient complications reported.
Additional Manufacturer Narrative
E1.Initial reporter phone updated.E1.Initial reporter email updated.
Event or Problem Description
It was reported that removal difficulties were encountered and the balloon cut the sheath.The target lesion was located in the left brachial access.A 6.00mm/2.0cm/90cm peripheral cutting balloon (pcb) was selected for use.During removal of the pcb, resistance was felt upon entering the sheath.The device was removed and continued to treat the lesion with a drug coated balloon.However, some bleeding was noticed at the sheath site and after examining the sheath it was noticed that it had been compromised by a horizontal cut.No patient complications reported.It was further reported that the percentage of stenosis was 50%, and lesion had focal severity of calcification and very little of tortuousity.Also, the balloon was slowly removed after proper deflation.The bleeding was noted only after the removal of the sheath.
Additional Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that removal difficulties were encountered and the balloon cut the sheath.The target lesion was located in the left brachial access.A 6.00mm/2.0cm/90cm peripheral cutting balloon (pcb) was selected for use.During removal of the pcb, resistance was felt upon entering the sheath.The device was removed and continued to treat the lesion with a drug coated balloon.However, some bleeding was noticed at the sheath site and after examining the sheath it was noticed that it had been compromised by a horizontal cut.No patient complications reported.It was further reported via medwatch # (b)(4) that the percentage of stenosis was 50%, and lesion had focal severity of calcification and very little of tortuousity.Also, the balloon was slowly removed after proper deflation.The bleeding was noted only after the removal of the sheath.In addition, a cutting balloon was used to open the artery that supplies the arm endovascularly.During removal, the blades of the device lacerated the artery of the patient at the entry site as well as the sheath which was removed.The blades are supposed to be retracted to prevent any damage when the balloon was deflated.However, the blades are not visible under fluoroscopy.An immediate open surgical procedure was necessary do to an increasing hematoma and loss of circulation to the patient's hand.The surgical procedure was successful.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12569133
• Report Number: 2134265-2021-12347
• Device Sequence Number: 4053606
• Product Code: PNO
• UDI-Device Identifier: 08714729813743
• UDI-Public: 08714729813743
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2021

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: 09/30/2021
• Device Model Number: 24630
• Device Catalogue Number: 24630
• Device Lot Number: 0024521367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 10/06/2021; 10/22/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 10/28/2021; 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 59 KG