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

Model Number H74939202070540

Device Problems Tear, Rip or Hole in Device Packaging (2385); Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Date 07/23/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the product pouches were opened.During un-packaging of a offroad re-entry system, prior to the procedure, the product shelf carton was removed and the two inner pouches were found open and one was torn.The devices were not used n the patient.

Manufacturer Narrative

Device evaluated by manufacturer: received for analysis was the outer box and inside this box was the box containing the micro catheter and the box containing the balloon catheter.An examination of the outer box identified that the bsc closure strip was intact but that the box had been ripped open at the other end.When both inner boxes were removed it was noted that they were both opened.An examination of the inner pouches containing the micro catheter and the balloon catheter, confirmed that these had been ripped open.An impression of their original seals was evident and even part of the inner packaging for the balloon catheter had been ripped.All packaging showed clear signs of having been intentionally opened.There were no visible signs of any device use.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred prior to patient contact.(b)(4).

Event Description

It was reported the product pouches were opened.During un-packaging of a offroad re-entry system, prior to the procedure, the product shelf carton was removed and the two inner pouches were found open and one was torn.The devices were not used n the patient.

• Brand Name: OFFROAD¿
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5015406
• MDR Text Key: 23474723
• Report Number: 2134265-2015-05717
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: ZA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2017
• Device Model Number: H74939202070540
• Device Catalogue Number: 39202-07054
• Device Lot Number: 16984597
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2014
• 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