MAUDE Adverse Event Report: IMAGER II ANGIOGRAPHIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 38270

Device Problem Unsealed Device Packaging (1444)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that seal compromised occurred.An imager catheter was inspected upon receipt of the device.During inspection, it was detected that imager angiographic catheter was damaged.The packaging was open on the side of the boston box.No patient was involved as it did not occur during a procedure.

Manufacturer Narrative

Device evaluated by mfr: returned product to boston scientific consisted of 5 imager diagnostic catheter in the original sterile package inside the cardboard outer carton.The outer package, sterile pouch and devices were checked for damage.The outer packaging was severely bent and creased on multiple areas.The devices inside showed bending and the sterile pouches showed creasing relating to the outside outer package.Inspection of the device pouches showed 1 pouch that was slightly opened on the side seal.No other pouches showed no damage.Inspection of the remainder of the devices, apart from the observed damage, revealed no other damage or irregularities.The reported complaint was confirmed for package/pouch damage.E1: fax -(b)(6).

Event Description

It was reported that seal compromised occurred.An imager catheter was inspected upon receipt of the device.During inspection, it was detected that imager angiographic catheter was damaged.The packaging was open on the side of the boston box.No patient was involved as it did not occur during a procedure.

• Brand Name: IMAGER II ANGIOGRAPHIC CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 9836323
• MDR Text Key: 183568690
• Report Number: 2134265-2020-03306
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729354888
• UDI-Public: 08714729354888
• Combination Product (y/n): N
• PMA/PMN Number: K121694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2021
• Device Model Number: 38270
• Device Catalogue Number: 38270
• Device Lot Number: 0000145225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Date Manufacturer Received: 06/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2019
• 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