MAUDE Adverse Event Report: 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 Patient Involvement (2645)
Date of Event	04/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2018 based on aware date and occurrences of previous referenced events.Device evaluated by manufacturer: returned product to boston scientific consisted of an imager diagnostic catheter in the sterile pouch.It was reported that the device tip was broken intentionally by the customer.The device was examined for damage or any irregularities.The device showed multiple areas of bends/kinks.The kinks that were noticed on the device were due to the shipment of the device in the folded manner.It was noticed inside of the sterile pouch that the tip was separated from the shaft.Inspection of the remainder of the device, apart from the observed damage revealed no damage or irregularities.The complaint stated that the physician broke the tip to prove the fragility of the tip; however it is not possible to determine how much force the physician used to break the tip and no way of determining how that would compare to the device design force specification.
Event or Problem Description
The hospital previously experienced tip detachments with three 5fr imager ii angiographic catheters captured within manufacturer report #s 2134265-2018-03728, 2134265-2018-04054, and 2134265-2018-04096.The physician and his team took this 5fr imager ii angiographic catheter of the same batch and purposely broke the tip of the catheter to prove the fragility of the device.The catheter was not used on a patient.This event is associated with previously reported field action (b)(4) with product being removed from the field.

• Brand Name: IMAGER II ANGIOGRAPHIC CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 10577659
• Report Number: 2134265-2020-13242
• Device Sequence Number: 11567186
• Product Code: DQO
• UDI-Device Identifier: 08714729355496
• UDI-Public: 08714729355496
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Nurse
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/23/2020

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: 11/30/2018
• Device Model Number: 38270
• Device Catalogue Number: 38270
• Device Lot Number: 0000118462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 09/23/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• 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