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

Model Number	38265
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that device tip detachment occurred.An imager ii diagnostic catheter was selected for use.During the procedure it was observed that the catheter tip detached.The detached tip was snared and the procedure was completed with another device.No patient complications were reported.
Event or Problem Description
It was reported that device tip detachment occurred.An imager ii diagnostic catheter was selected for use.During the procedure it was observed that the catheter tip detached.The detached tip was snared and the procedure was completed with another device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an imager diagnostic catheter.The device was inspected for any damage.It was noticed that the device showed a separated tip approximately 3cm from the tip.No other damage was noticed on the devices 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: 9371670
• Report Number: 2134265-2019-14438
• Device Sequence Number: 14034870
• Product Code: DQO
• UDI-Device Identifier: 08714729355892
• UDI-Public: 08714729355892
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K120893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/25/2020
• Device Model Number: 38265
• Device Catalogue Number: 38265
• Device Lot Number: 0000134946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 01/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention