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

Model Number	38270
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that a foreign material inside the catheter was observed.An imager angiographic catheter was selected for use for a carotid angiogram in the carotid artery.During preparation when attempting to flush the catheter, it was noted that there was a piece of plastic inside the catheter that popped out upon flushing.The same issue with two other imager catheters.The devices did not enter the patients body.There were no patient complications reported.
Additional Manufacturer Narrative
Mfg.Site email - (b)(4).Device evaluated by mfr: the imager diagnostic catheter was returned for evaluation.The shaft and the remainder of the device were checked for damage.Visual examination showed no damage to the shaft.The device was returned with a piece of plastic, that was reported of being extruded from the shaft during the flushing process.The complaint was confirmed for fm in the lumen.Inspection of the remainder of the device, revealed no other damage or irregularities.
Event or Problem Description
It was reported that a foreign material inside the catheter was observed.An imager angiographic catheter was selected for use for a carotid angiogram in the carotid artery.During preparation when attempting to flush the catheter, it was noted that there was a piece of plastic inside the catheter that popped out upon flushing.The same issue with two other imager catheters.The devices did not enter the patients body.There were no patient complications reported.

• 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: 8662979
• Report Number: 2134265-2019-06159
• Device Sequence Number: 2118083
• Product Code: DQO
• UDI-Device Identifier: 08714729354949
• UDI-Public: 08714729354949
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K121694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2019

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: 03/11/2021
• Device Model Number: 38270
• Device Catalogue Number: 38270
• Device Lot Number: 0000139449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 06/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1