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

Model Number	24686
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The gladiator elite 12.0 x40, 75cm, 14 atm was retuned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was present in the balloon which is indicative of a leak.The rated burst pressure for this device is 14 atmospheres as per gladiator elite specification.The returned device was attached to an encore inflation unit and positive pressure was applied and liquid was observed to be leaking from a balloon pinhole located approximately 14mm proximally of the proximal marker band.An examination of the balloon material and proximal marker band identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the tip of the device.A visual and tactile examination of the shaft identified multiple kinks along the length of the shaft.A visual examination found no issues or damage to the markerbands of the device.
Event or Problem Description
Reportable based on device analysis completed on 14oct2021.It was reported that balloon leak occurred.A 12.0 x40, 75cm gladiator elite balloon catheter was selected for use.However, during preparation the balloon leaked when testing it with water.The procedure was completed with another of the same device.There were no patient complications reported.However, returned device analysis revealed a balloon pinhole.

• 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: 12727983
• Report Number: 2134265-2021-13288
• Device Sequence Number: 1558671
• Product Code: LIT
• UDI-Device Identifier: 08714729809555
• UDI-Public: 08714729809555
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/01/2021

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: 03/11/2022
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0023471883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 11/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 52