MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER; CATHETER, PERCUTANEOUS

Model Number 26102

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter state: (b)(6).

Event Description

It was reported that a balloon rupture occurred.A 5 x 120mm, 150cm ranger (dcb) balloon was advanced to the target lesion, but while attempting the first inflation, it was noticed that the balloon had already ruptured.It was noted that the balloon would not inflate and contrast was visibly leaking through the balloon on imaging.The device was removed intact.An attempt to inflate the balloon was made outside the patient, and it was confirmed that there was a rupture.The procedure was completed with another balloon.No patient complications were reported in relation to this event.

• Brand Name: RANGER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): HEMOTEQ AG; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10596306
• MDR Text Key: 208847226
• Report Number: 2134265-2020-13005
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2021
• Device Model Number: 26102
• Device Catalogue Number: 26102
• Device Lot Number: 20469H19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2019
• 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