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

Model Number	38270
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 9836323
• Report Number: 2134265-2020-03306
• Device Sequence Number: 19157439
• Product Code: DQO
• UDI-Device Identifier: 08714729354888
• UDI-Public: 08714729354888
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K121694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 07/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1