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

Model Number H965SCH505110

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Date 03/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the device became contaminated during unpacking.During unpacking of a 6.0-80, 80 (b)(6) balloon catheter, when the box was opened, 'the balloon exited immediately' from the package and it was desterilized.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.Received for analysis was the outer box, inner packaging and the wanda balloon catheter.The outer box was torn open.No other damage was present.The wanda device was free moving in the opened inner packaging.The inner tray was not returned for analysis.An examination of the balloon catheter identified no issues.There was no evidence 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 without direct patient contact.(b)(4).

Event Description

It was reported that the device became contaminated during unpacking.During unpacking of a 6.0-80, 80 wanda balloon catheter, when the box was opened, 'the balloon exited immediately' from the package and it was desterilized.No patient complications were reported.

• Brand Name: WANDA¿
• 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: 6483143
• MDR Text Key: 72511067
• Report Number: 2134265-2017-03766
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2019
• Device Model Number: H965SCH505110
• Device Catalogue Number: SCH-50511
• Device Lot Number: 20131604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2017
• 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