MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SPIROFLEX; CATHETER, EMBOLECTOMY

Model Number 10706

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 04/29/2019

Event Type  malfunction  

Event Description

It was reported that the device packaging was not sealed.An angiojet spiroflex catheter was selected for a arterial thrombectomy procedure of the lower leg.When the device packaging was opened, it was noted that the inside packaging was not completely sealed.The paper had peeled away from the plastic base.A new device of the same model was selected to complete the procedure.The patient experienced no complications and is fine.

Manufacturer Narrative

Device evaluation by mfr: the returned product consisted of a spiroflex thrombectomy system inside the packaging.The product pouch and tray packaging were visually inspected.The product pouch was opened by the facility, as the bsc seal was intact and the tyvek seal was opened.The tyvek on the tray was noticed to be half open.The tray and tyvek were inspected, and it was found that the seal on the unsealed portion of the tray was incomplete.Inspection of the remainder of the packaging presented no damage or other irregularities.

Event Description

It was reported that the device packaging was not sealed.An angiojet spiroflex catheter was selected for an arterial thrombectomy procedure of the lower leg.When the device packaging was opened, it was noted that the inside packaging was not completely sealed.The paper had peeled away from the plastic base.A new device of the same model was selected to complete the procedure.The patient experienced no complications and is fine.

• Brand Name: ANGIOJET SPIROFLEX
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8632588
• MDR Text Key: 145792180
• Report Number: 2134265-2019-05583
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• PMA/PMN Number: K072769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10706
• Device Catalogue Number: 10706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Date Manufacturer Received: 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1