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

Model Number	24630
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon deflation failure occurred and trauma of pulling out the balloon caused bleeding.A 8.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During a biliary stricture protocol procedure, the balloon was inflated for treatment and following the completion of treatment, several attempts were made to deflate the balloon to no avail.Fluoroscopy was used to confirm whether the balloon was still inflated, which was indeed the case.As a last resort effort, the provider forcefully pulled both the sheath and inflated balloon out of the patient promptly placing a new biliary drainage catheter.The trauma of pulling out the still fully inflated balloon caused bleeding from the entry site that sustained both in the procedure room and in the recovery area for up to 4 hours.The procedure was completed, and no further patient complications were reported; the patient fully recovered.
Event or Problem Description
It was reported that balloon deflation failure occurred and trauma of pulling out the balloon caused bleeding.A 8.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During a biliary stricture protocol procedure, the balloon was inflated for treatment and following the completion of treatment, several attempts were made to deflate the balloon to no avail.Fluoroscopy was used to confirm whether the balloon was still inflated, which was indeed the case.As a last resort effort, the provider forcefully pulled both the sheath and inflated balloon out of the patient promptly placing a new biliary drainage catheter.The trauma of pulling out the still fully inflated balloon caused bleeding from the entry site that sustained both in the procedure room and in the recovery area for up to 4 hours.The procedure was completed, and no further patient complications were reported; the patient fully recovered.
Additional Manufacturer Narrative
Device evaluated by mfr: a pcb device was returned for analysis inserted in a introducer sheath with a syringe attached to the hub.The device was received with the balloon inflated and inserted through the customer's introducer sheath.The investigator was unable to deflate the balloon due to the severe kinks along the length of the shaft.The rated burst pressure for this device is 10 atmospheres as per specification.A visual examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.A visual and tactile examination identified severe multiple shaft kinks along the length of the device.No other issues were identified during the product analysis.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14976736
• Report Number: 2134265-2022-07431
• Device Sequence Number: 5073542
• Product Code: PNO
• UDI-Device Identifier: 08714729813804
• UDI-Public: 08714729813804
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2022

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: 12/16/2023
• Device Model Number: 24630
• Device Catalogue Number: 24630
• Device Lot Number: 0028568753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2021
• 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
• Patient Sex: Unknown