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

Model Number 38270

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 05/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event 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.

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 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
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8662979
• MDR Text Key: 146808172
• Report Number: 2134265-2019-06159
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729354949
• UDI-Public: 08714729354949
• Combination Product (y/n): N
• PMA/PMN Number: K121694
• 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: 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
• Device Operator: 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 Manufacturer Received: 05/17/2019
• Initial Date FDA Received: 06/03/2019
• Supplement Dates Manufacturer Received: 06/04/2019
• Supplement Dates FDA Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1