MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE RANGER; CATHETER, PERCUTANEOUS

Model Number H74939219501080

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.(b)(4).

Event Description

It was reported that during the unpackaging of a 5.0 mm x 100 mm, 80 cm ranger drug coated balloon, it was noted the side of the sterile package was unsealed.The product was not used.

Manufacturer Narrative

Device evaluated by manufacturer: a visual examination identified the returned device consisted of the device in its primary packaging.The manufacturer¿s seal was missing.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause has been determined to be related to a supplier manufacturing issue.(b)(4).

Event Description

It was reported that during the unpackaging of a 5.0 mm x 100 mm, 80 cm ranger drug coated balloon, it was noted the side of the sterile package was unsealed.The product was not used.

• Brand Name: RANGER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5664915
• MDR Text Key: 45473639
• Report Number: 2134265-2016-04594
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• 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,Followup
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: H74939219501080
• Device Catalogue Number: 39219-50108
• Device Lot Number: 3472H15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2015
• 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