MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IMPULSE GUIDE CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	8161
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer site address: (b)(4).
Event or Problem Description
It was reported that contamination occurred.Contamination was observed inside the sealed pouch of a model-6f impulse diagnostic catheter prior to use.No adverse patient effects occurred as a result of this event.
Additional Manufacturer Narrative
G1: manufacturer site address - (b)(6).Device evaluated by manufacturer: returned product consisted of the 6f impulse diagnostic catheter inside the sealed product pouch.A photo was also reviewed for analysis.The photo was reviewed for the reported packaging contamination.The photo is of the distal end of the curved shaft and tip with the plastic sleeve and securement label.As it was reported that the issue was in the photo, it is correct to assume that the plastic sleeve and the securement label is what the facility is referring to.The packaging, hub, shaft, and tip were visually examined.Inspection of the device revealed that the device was received in the sealed product pouch on the product card.The device was inspected through the product pouch and there was no fm present.The only things in the sealed product pouch were the product card, the device, the plastic sleeve and a securement label.All these things are supposed to be in the sealed pouch per the manufactured procedure.It was confirmed through the attached photo in the complaint record, that the protective sleeve and securement label is to help maintain the curve during transport and is to be included per process.Product analysis did not confirm the reported event, as there was no fm/packaging contamination.
Event or Problem Description
It was reported that contamination occurred.Contamination was observed inside the sealed pouch of a model-6f impulse diagnostic catheter prior to use.No adverse patient effects occurred as a result of this event.

• Brand Name: IMPULSE GUIDE CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): AVAIL MEDICAL PRODUCTS INCORPORATED; san diego CA 92121
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12704802
• Report Number: 2134265-2021-13513
• Device Sequence Number: 4498899
• Product Code: DQO
• UDI-Device Identifier: 08714729200246
• UDI-Public: 08714729200246
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K120495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2021

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: Other
• Device Expiration Date: 06/19/2023
• Device Model Number: 8161
• Device Catalogue Number: 8161
• Device Lot Number: 0060302541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown