MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY GLADIATOR¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number H74939207070470

Device Problems Break (1069); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/05/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that balloon rupture and shaft break occurred.A 7.0 x 40, 75cm gladiator¿ balloon catheter was advanced for dilatation.However, during inflation at around or a little above the rated burst pressure, the balloon ruptured and was torn circumferentially.When device removal was attempted, it broke into three pieces inside the patient's body.Subsequently, a snare was used to successfully retrieve all the broken pieces.No patient complications were reported and the patient's status was fine; however, the event caused the procedure to take two hours longer.

Manufacturer Narrative

Device evaluated by mfr, eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr: the complaint device was returned for analysis.A visual examination of the returned device identified a longitudinal with complete circumferential tear in the balloon material.The balloon had become separated at the point of the circumferential tear, leaving 32 mm of longitudinally torn balloon material still attached to the proximal piece of the device.The balloon material from the detached distal section of the balloon tear was bunched over the proximal end of the device¿s tip.Both pieces of the balloon were retrieved from the patient¿s body.Due to the condition of the returned device the markerbands were no longer attached to the device and could not be examined.The tip was detached completely from the device.The distal section of detached balloon material was bunched over the proximal tip.No issues were identified with the tip of the device which may have contributed to the complaint incident.A visual examination confirmed that the shaft within the balloon was broken into two pieces.Both pieces were retrieved from the patient¿s body and returned for analysis.Part of the shaft which was completely separated from the device measured 27 mm in length.The damage observed is consistent with excessive force being applied and the navigation of difficult patient anatomy.No damage was noted on the proximal part of the device shaft.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

It was reported that balloon rupture and shaft break occurred.A 7.0 x 40, 75 cm gladiator¿ balloon catheter was advanced for dilatation.However, during inflation at around or a little above the rated burst pressure, the balloon ruptured and was torn circumferentially.When device removal was attempted, it broke into three pieces inside the patient's body.Subsequently, a snare was used to successfully retrieve all the broken pieces.No patient complications were reported and the patient's status was fine; however, the event caused the procedure to take two hours longer.

• Brand Name: GLADIATOR¿
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6516527
• MDR Text Key: 73525602
• Report Number: 2134265-2017-04096
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: H74939207070470
• Device Catalogue Number: 3920707047
• Device Lot Number: 0020229551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention