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

Model Number	24686
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation by mfr.: gladiator device - 7x40x75cm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.Blood was identified within the balloon which is evidence of a device leak.A microscopic examination identified a balloon longitudinal tear beginning at the proximal bond and extending approximately 20mm distally across the balloon material.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 damage to the tip which may have potentially contributed to the complaint incident.No issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 14aug2020.It was reported that crossing difficulty was encountered.The target lesion was located in the radial artery.A 7.0 x40, 75cm gladiator balloon catheter was advanced but failed to cross the lesion.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.However, returned device analysis revealed longitudinal balloon tear.

• 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: 10503252
• Report Number: 2134265-2020-12474
• Device Sequence Number: 3155327
• Product Code: LIT
• UDI-Device Identifier: 08714729809791
• UDI-Public: 08714729809791
• 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
• Report Date (Section B): 09/08/2020

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: 06/10/2022
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0023935718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 09/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 59