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

Model Number 38265

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2021

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 280511322
• Report Number: 2134265-2021-13828
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729355946
• UDI-Public: 08714729355946
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1