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

Model Number	38265
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: imager ii/5/straight/65/035 sgl was returned for analysis.Returned product to boston scientific consisted of an imager diagnostic catheter in an unopened sterile pouch.The device was examined for damage or any irregularities.The sterile pouch showed damage and a hole was observed.The sterile pouch was opened, and the device showed a smashed hub matching where the pouch damage was.No other damage was noticed.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint was confirmed for hub damage as well as sterile pouch damage.
Event or Problem Description
It was reported that hub damaged occurred.An imager ii angiographic catheter was selected for use.During preparation, upon opening the package they noticed the hub was smashed and they were unable to use it.The procedure was completed with an alternate method/device.There were no patient complications reported.However, returned device analysis revealed sterile pouch damage.

• Brand Name: IMAGER II
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): TFX ENGINEERING LIMITED T/A; unit 7 8 and 9; annacotty, li ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12778076
• Report Number: 2134265-2021-13828
• Device Sequence Number: 14345685
• Product Code: DQO
• UDI-Device Identifier: 08714729355946
• UDI-Public: 08714729355946
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/09/2021

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: 08/31/2022
• Device Model Number: 38265
• Device Catalogue Number: 38265
• Device Lot Number: 0000154242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown