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

Model Number	24686
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft hole/perforated occurred.The target lesion was located in the right arm.A 12.0x40mm gladiator elite balloon catheter was advanced for dilatation.However, as the balloon was pulled negative, backflow of blood in the inflation syringe was noted due to a pinhole somewhere in the catheter.The procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: gladiator elite 8.0 x 40, 75 cm device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was observed in the balloon body indicating presence of a leak.The returned device was attached to an encore inflation unit and positive pressure was applied to inflate the balloon.The balloon could not be inflated due to the presence of solidified media that was present within the inflation lumen.The device was soaked in a water bath at a temperature of 37 degrees celsius to help soften the media before further inflation attempts were made.The returned device was again attached to a boston scientific encore inflation unit and positive pressure was applied to inflate the balloon and liquid was observed to be leaking from a balloon pinhole located at approximately 9 mm from the distal end of the proximal markerband.The rated burst pressure for this device is 20 atmospheres.A visual and microscopic examination observed no issues with the tip of the device which could potentially have contributed to the complaint incident.A visual and tactile examination found no kinks or damage along the shaft of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that shaft hole/perforated occurred.The target lesion was located in the right arm.A 12.0x40mm gladiator elite balloon catheter was advanced for dilatation.However, as the balloon was pulled negative, backflow of blood in the inflation syringe was noted due to a pinhole somewhere in the catheter.The procedure was completed with another of same device.No 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: 9180180
• Report Number: 2134265-2019-12019
• Device Sequence Number: 11733651
• Product Code: LIT
• UDI-Device Identifier: 08714729809876
• UDI-Public: 08714729809876
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K132810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

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 Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0024028510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR