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

Model Number 38265

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/01/2019

Event Type  malfunction  

Event 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 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.

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
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9198654
• MDR Text Key: 164327846
• Report Number: 2134265-2019-12468
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729356059
• UDI-Public: 08714729356059
• Combination Product (y/n): N
• PMA/PMN Number: K120893
• 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: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1