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

Model Number	24630
Medical Device Problem Codes	Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a metallic piece protruded upon removal.The 80% stenosed target lesion was located in the mildly tortuous and non-calcified graft to axillary vein anastomosis.A 7.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.Upon removal of the balloon, balloon was fully deflated and when removed over the wire from the sheath a metallic piece was protruding from it, likely one of the cutting components of the balloon.A completion fistula gram was performed though the sheath showing good flow through the graft.The device was deflated angiographically and the sheath was removed over the v18 wire intact; however there was an approximately 1 inch cut lengthwise in the sheath that appeared to have been made from a sharp cut and was confirmed caused by the balloon as it was not present prior to the used of the balloon.As per physician's opinion, the blade lifted was possibly caused from the inflation at the lesion.The patient was taken to recovery in stable condition.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was not folded, and inflation media was present inside it which indicates that the balloon was subjected to positive pressure.The returned device was attached to an encore inflation unit and positive pressure was applied, the balloon was inflated to its rate of burst pressure of 10 atmospheres for 30 seconds using digital timer: (b)(6), without issue.A vacuum was then applied.The inflation device was verified at 12 atmospheres, before and after use with calibrated pressure gauge (b)(6).This inflation to rate of burst pressure of 10 atmospheres was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.The rated burst pressure for this device is 10 atmospheres as per 2cm pcb specification.A visual examination was performed on the returned device.It was noted that approximately 5mm of one blade and blade pad was lifted distally from the balloon material.The remaining 15mm of the blade and blade pad was full bonded to the balloon material.The damage identified is consistent with excessive force being applied when resistance is encountered during the withdrawal of the device through the sheath.All other blades were intact and fully bonded to the balloon material.No issue was observed with the tip or marker bands of the device which could have contributed to the complaint incident.A visual and tactile examination found no kinks or damage to the shaft of the device.
Event or Problem Description
It was reported that a metallic piece protruded upon removal.The 80% stenosed target lesion was located in the mildly tortuous and non-calcified graft to axillary vein anastomosis.A 7.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.Upon removal of the balloon, balloon was fully deflated and when removed over the wire from the sheath a metallic piece was protruding from it, likely one of the cutting components of the balloon.A completion fistula gram was performed though the sheath showing good flow through the graft.The device was deflated angiographically and the sheath was removed over the v18 wire intact; however there was an approximately 1 inch cut lengthwise in the sheath that appeared to have been made from a sharp cut and was confirmed caused by the balloon as it was not present prior to the used of the balloon.As per physician's opinion, the blade lifted was possibly caused from the inflation at the lesion.The patient was taken to recovery in stable condition.

• 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: 15527863
• Report Number: 2124215-2022-38049
• Device Sequence Number: 6079393
• Product Code: PNO
• UDI-Device Identifier: 08714729813774
• UDI-Public: 08714729813774
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2022

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: 07/20/2023
• Device Model Number: 24630
• Device Catalogue Number: 24630
• Device Lot Number: 0027697452
• 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: 09/07/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 10/03/2022
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE-V18; GUIDEWIRE-V18
• Patient Sex: Unknown