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

Model Number	38270
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	07/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem 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.
Additional Manufacturer Narrative
A2: age at time of event - 18 years or older.
Event or Problem 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
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10308647
• Report Number: 2134265-2020-09700
• Device Sequence Number: 3417047
• Product Code: DQO
• UDI-Device Identifier: 08714729355496
• UDI-Public: 08714729355496
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2020

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: 10/12/2020
• Device Model Number: 38270
• Device Catalogue Number: 38270
• Device Lot Number: 0000135360
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 92484513-FA
• Patient Sequence Number: 1