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

Model Number	24686
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon became stuck, ruptured and was difficult to remove from the stent.An 8.0 x40, 75cm gladiator elite balloon catheter was advanced for post-dilatation.However, upon going through a new stent, the balloon became stuck on the stiff glide.Consequently, the balloon ripped and was difficult to remove from the stent.The device was removed through the sheath and no device fragment was left inside the patient.The procedure was completed successfully.No patient complications were reported.
Additional Manufacturer Narrative
B3 - date of event: date of event was approximated to 07/01/2024 as the exact event date was not reported.
Additional Manufacturer Narrative
B3 - date of event: date of event was approximated to 07/01/2024 as the exact event date was not reported.Corrected d4: lot number from 0033890357 to 0033577175.Corrected d4: expiration date from 04/24/2027 to 03/07/2027.Corrected h4: device manufacture date from 04/24/2024 to 03/07/2024.Device was returned for evaluation.The recommended guidewire size for this device is 0.035" as per specification.The guidewire used by the customer was not returned for analysis.The investigator was unable to load the device on to a boston scientific 0.035" guidewire due to shaft damage.A visual examination identified that the balloon was not folded, which indicates that the device was subjected to positive pressure.A leak test was carried out and the balloon was inflated to its rated burst pressure for 30 seconds using deionized water and digital timer without issue.A vacuum was then applied.The inflation device was verified at 20 atmospheres, before and after use with calibrated pressure gauge.This inflation to rate of burst pressure was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.As per specification, the rated burst pressure for this device is 20 atmospheres.No issues were noted with the tip of the device.A visual examination found no issue with the markerbands.A visual and tactile examination found the shaft of the device to be kinked at more than one location.No other issues were identified with the device and no patient complications were reported.
Event or Problem Description
It was reported that balloon became stuck, ruptured and was difficult to remove from the stent.An 8.0 x40, 75cm gladiator elite balloon catheter was advanced for post-dilatation.However, upon going through a new stent, the balloon became stuck on the stiff glide.Consequently, the balloon ripped and was difficult to remove from the stent.The device was removed through the sheath and no device fragment was left inside the patient.The procedure was completed successfully.No patient complications were reported.

• Brand Name: GLADIATOR ELITE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19930162
• Report Number: 2124215-2024-45443
• Device Sequence Number: 2736597
• Product Code: LIT
• UDI-Device Identifier: 08714729809876
• UDI-Public: 08714729809876
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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: 0033577175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2024
• 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
• Patient Sex: Unknown