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

Model Number	38265
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a hole on a catheter was observed.An imager angiographic catheter was selected for use.A hole was observed on the catheter.No patient complications were reported.
Event or Problem Description
It was reported that a hole on a catheter was observed.An imager angiographic catheter was selected for use.A hole was observed on the catheter.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.The device was inspected for any damage.It was noticed that the device showed multiple kinks along the shaft.There was no damage pertaining to a hole in the catheter shaft.Inspection of the remainder of the device, apart from the observed damage on the box, revealed no other damage or irregularities.

• Brand Name: IMAGER II ANGIOGRAPHIC CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9198654
• Report Number: 2134265-2019-12468
• Device Sequence Number: 2639588
• Product Code: DQO
• UDI-Device Identifier: 08714729356059
• UDI-Public: 08714729356059
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2019

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: 05/22/2021
• Device Model Number: 38265
• Device Catalogue Number: 38265
• Device Lot Number: 0000141660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1