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

Model Number 38270

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that the tip broke off.A 5f c2 imager ii angiographic catheter was selected for a ureteric stent insertion procedure.An antegrade approach was used via the left nephrostomy tube.The imager ii catheter was placed into the entry sheath after being flushed with heparinized saline and lubricated with normal saline.When the catheter was in the left ureter, it was discovered that the distal tip was broken off but still attached to the catheter.The catheter was removed and discarded.Another of the same product and batch number was opened.During inspection of the catheter, which involved flushing and lubricating, the distal tip of the catheter detached in the radiologist's hand.A third catheter was then opened to check the tip.The tip was very fragile and easily removed from the catheter.No patient complications were reported, and the patient was stable post-procedure.The patient was admitted for routine observations post-procedure as pre-planned, and no escalation of care was required.

Manufacturer Narrative

A2: age at time of event - 18 years or older.

Event Description

It was reported that the tip broke off.A 5f c2 imager ii angiographic catheter was selected for a ureteric stent insertion procedure.An antegrade approach was used via the left nephrostomy tube.The imager ii catheter was placed into the entry sheath after being flushed with heparinized saline and lubricated with normal saline.When the catheter was in the left ureter, it was discovered that the distal tip was broken off but still attached to the catheter.The catheter was removed and discarded.Another of the same product and batch number was opened.During inspection of the catheter, which involved flushing and lubricating, the distal tip of the catheter detached in the radiologist's hand.A third catheter was then opened to check the tip.The tip was very fragile and easily removed from the catheter.No patient complications were reported, and the patient was stable post-procedure.The patient was admitted for routine observations post-procedure as pre-planned, and no escalation of care was required.It was further reported that the procedure was completed with a different device.

• 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: 10308661
• MDR Text Key: 199886749
• Report Number: 2134265-2020-09699
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729355496
• UDI-Public: 08714729355496
• 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,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2020
• Device Model Number: 38270
• Device Catalogue Number: 38270
• Device Lot Number: 0000135360
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 92484513-FA
• Patient Sequence Number: 1