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

Model Number	38265
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device eval by manufacturer: the device was returned for analysis.The device was inspected for any damage.The device was returned in the opened sterile pouch still in the cardboard tabs.It was noticed that the device showed a broken shaft in 1 location and a separation in another location.The break was approximately 4cm from the tip and the separated portion was approximately 3cm from the tip.The separated portion was not returned.The device as manufactured is 100cm long, there was a total of 97cm returned which equals to 3cm of the tip that was not returned.There was 1 kink noticed on the shaft located approximately 20cm from the strain relief.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
Reportable based on device analysis completed on 24jan2020.An imager ii/5/pigtail/100/038 bx5 angiographic catheter returned with no known complaint.Device analysis found the tip was separated.It was further reported that the device was not used in a procedure.The device was tested at the hospital warehouse and was found to be fractured.

• 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: 9706536
• Report Number: 2134265-2020-01285
• Device Sequence Number: 3319576
• Product Code: DQO
• UDI-Device Identifier: 08714729355892
• UDI-Public: 08714729355892
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K120893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 02/13/2020

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: 07/16/2020
• Device Model Number: 38265
• Device Catalogue Number: 38265
• Device Lot Number: 0000133448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 02/13/2020
• 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