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

Model Number 26102

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown.Bsc became aware of the event on (b)(6) 2020.Therefore, a date of (b)(6) 2020 was entered to indicate that the event occurred on an unknown day in (b)(6) 2020.

Event Description

It was reported that a packaging issue occurred.During preparation, while outside the patient, and after the package to a 4.0mm x 40mm, 80cm ranger balloon was opened, it was noticed that the internal packaging was already open.The procedure was completed with another of the same device.No patient complications were reported and the patient was reported to be stable following the procedure.

Manufacturer Narrative

B3: date of event is unknown.Bsc became aware of the event on 24 april 2020.Therefore, a date of (b)(6) 2020 was entered to indicate that the event occurred on an unknown day in (b)(6) 2020.Device evaluated by mfr: returned product consisted of a ranger balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.No packaging was received with the device.The balloon was loosely folded for 15mm starting at the proximal end of the balloon.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis was unable to confirm the reported packaging issue.

Event Description

It was reported that while outside the patient an unknown issue with ranger balloon occurred.The patient was stable following the procedure.It was further reported that a packaging issue occurred.During preparation,while outside the patient, and after the ranger pack was opened, it was noticed that the internal packaging to a 4.0mm x 40mm, 80cm ranger balloon was already open.The procedure was completed with another of the same device.No patient complications were reported and the patient was reported to be stable following the procedure.

• Brand Name: RANGER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10078529
• MDR Text Key: 191718344
• Report Number: 2134265-2020-06637
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2021
• Device Model Number: 26102
• Device Catalogue Number: 26102
• Device Lot Number: 13417H19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Date Manufacturer Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1