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

Model Number H74939207120470

Device Problem Hole In Material (1293)

Patient Problems High Blood Pressure/ Hypertension (1908); Tachycardia (2095)

Event Date 11/22/2017

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).(b)(6).Device evaluated by mfr: the device was returned.A visual and microscopic examination was performed on the returned device.The hub/manifold had been dissected from the device by the nurse and was not returned for analysis.A visual and tactile examination identified that the shaft had been lacerated 651mm proximal to the proximal balloon bond.No issues were noted with the shaft of the device that could have contributed to the complaint incident.The balloon was unfolded which indicates it had been subjected to positive pressure.Solidified blood was observed within the balloon which is evidence of a device leak.Due to the condition of the returned device it was not possible to inflate the balloon with an encore inflation unit.In order to assess of the balloon material, the investigator injected liquid into the inflation lumen which inflated the balloon material.Once the balloon material was inflated the investigator palpated the balloon and liquid was noted escaping from a pinhole leak in the balloon material approximately 6mm distal to the distal edge of the distal markerband.A visual and microscopic examination of the balloon material identified no issues that could have contributed to the complaint incident.A visual and microscopic examination found no issue with the markerbands or tip of the device that could have contributed to the complaint incident.No other issues were noted with the device during analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).

Event Description

It was reported that balloon pinhole and transient increased in patient's heart rate and blood pressure occurred.The target lesion was located in the iliac vein.Following pre-dilation with an 8mm balloon catheter, a stent was successfully implanted.A 12.0 x40 75cm gladiator¿ balloon catheter was then advanced for post-dilation.However, there was leakage on the balloon and a pinhole was noted.The patient's heart rate and blood pressure had increased for several seconds and it was resolved by the patient himself.The procedure was completed after the physician confirmed the angiography and satisfied with the stent expansion.No further patient complications were reported and the patient's status was stable.

• 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: 7392794
• MDR Text Key: 104191820
• Report Number: 2134265-2018-02615
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K113681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2020
• Device Model Number: H74939207120470
• Device Catalogue Number: 3920712047
• Device Lot Number: 0021125883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2018
• Initial Date FDA Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2017
• 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): Other