MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GLADIATOR ELITE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24686
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	06/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon pinhole occurred and the patient developed a hematoma.The target lesion was located in an upper arm vessel.A 5.0 x40, 40cm gladiator elite balloon catheter was advanced for dilatation.However, during the first inflation at 6 atmospheres, it was noticed that the balloon was leaking fluid.The device was removed and tested for pressure.It was found that there was a hole in the balloon.The long operation time resulted in the patient developing a hematoma in the upper arm.The patient was transferred to a different hospital and sent to surgery.No further patient complications were reported.
Additional Manufacturer Narrative
Device evaluation by mfr: gladiator device - 5x40x40cm, 24atm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 1mm proximal of the proximal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination found no kinks or damage to the shaft of the device.A visual and tactile examination identified no issues or damage to the tip of the device.No issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon pinhole occurred and the patient developed a hematoma.The target lesion was located in an upper arm vessel.A 5.0 x40, 40cm gladiator elite balloon catheter was advanced for dilatation.However, during the first inflation at 6 atmospheres, it was noticed that the balloon was leaking fluid.The device was removed and tested for pressure.It was found that there was a hole in the balloon.The long operation time resulted in the patient developing a hematoma in the upper arm.The patient was transferred to a different hospital and sent to surgery.No further patient complications were reported.

• Brand Name: GLADIATOR ELITE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10744073
• Report Number: 2134265-2020-14763
• Device Sequence Number: 3141318
• Product Code: LIT
• UDI-Device Identifier: 08714729809661
• UDI-Public: 08714729809661
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020

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: 08/22/2022
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0024315302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 12/04/2020
• 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: 56 YR
• Patient Weight: 61