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

Model Number	38270
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tip detachment occurred.An imager ii angiographic catheter was selected for use.The catheter was placed over a non-bsc guidewire.As the catheter tip was straightened it snapped at the apex of the tip angle.Another imager ii angiographic catheter was selected from the same lot number.Prior to use, the catheter tip was straightened manually to test if tip would break.The tip remained intact, and angiographic catheter was placed over non-bsc guidewire.As the catheter tip was straightened it snapped again at the apex of the tip angle.Another imager ii angiographic catheter was selected from a different lot number.The catheter was successfully loaded onto the non-bsc guidewire and the procedure was completed.Upon removal of the catheter, which had a non-bsc microcatheter within the device, it was noticed on fluoroscopy that the tip of the imager catheter had again snapped.The tip was free floating around the tip of the non-bsc microcatheter.The imager ii catheter and microcatheter were removed successfully from the sheath and patient.After the procedure the scrub nurse stated that the catheter tips felt brittle.
Additional Manufacturer Narrative
The device was returned for evaluation.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.
Event or Problem Description
It was reported that tip detachment occurred.An imager ii angiographic catheter was selected for use.The catheter was placed over a non-bsc guidewire.As the catheter tip was straightened it snapped at the apex of the tip angle.Another imager ii angiographic catheter was selected from the same lot number.Prior to use, the catheter tip was straightened manually to test if tip would break.The tip remained intact, and angiographic catheter was placed over non-bsc guidewire.As the catheter tip was straightened it snapped again at the apex of the tip angle.Another imager ii angiographic catheter was selected from a different lot number.The catheter was successfully loaded onto the non-bsc guidewire and the procedure was completed.Upon removal of the catheter, which had a non-bsc microcatheter within the device, it was noticed on fluoroscopy that the tip of the imager catheter had again snapped.The tip was free floating around the tip of the non-bsc microcatheter.The imager ii catheter and microcatheter were removed successfully from the sheath and patient.After the procedure the scrub nurse stated that the catheter tips felt brittle.

• 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: 9370638
• Report Number: 2134265-2019-14412
• Device Sequence Number: 11479807
• Product Code: DQO
• UDI-Device Identifier: 08714729355410
• UDI-Public: 08714729355410
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

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: 06/13/2020
• Device Model Number: 38270
• Device Catalogue Number: 38270
• Device Lot Number: 0000132447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1