MAUDE Adverse Event Report: VASCULAR TECHNOLOGY INCORPORATED, MIZUHO DISPOSABLE DOPPLER PROBE FOR NEUROSURGERY

Model Number 07-150-10

Device Problem Insufficient Information (3190)

Patient Problems Aneurysm (1708); Patient Problem/Medical Problem (2688)

Event Date 01/23/2020

Event Type  Injury  

Manufacturer Narrative

A 138660 doppler probe was given to engineering to investigate a complaint by a customer.Engineering received the doppler probe and complaint on 7/29/2020 at 1:00pm.Investigation was begun at 1:30pm on 7/29/2020.Probe had been sterilized by the customer and then disinfected by vascular technology upon receipt at the facility.The investigation protocol was as follows: inspect the probe for any visible damage or non-conformities, test probe for function, review customer complaint, conclusions.Results: probe was found to be intact and built to current specifications.There was a small indent in the shape of a v, in the white covering at the distal end.The indent was not significant measuring 0.014" wide at the end of the tube going 0.009" deep the indent was 0.040" away from the face of the probe and should not cause any problems by contacting the vessel.This indent would be acceptable for shipment.The indent may have occurred in manufacturing or at the customer.A review of tubing on similar probes did not show any tubing to have a similar indent.Probe was tested for function and found to be functioning properly.The customer stated that an injury occurred with the current doppler probe.They also stated that "the probe was no longer completely encased in a round-ended atraumatic plastic sheath, including the probe tip." the 138660 does not come with an atraumatic plastic sheath.Vascular technology has asked for additional information on the injury but sources were unable to provide this information, therefore with the evidence that was provided to us, it is determined that the probe was functioning properly at the time of use and that it met all of its design and engineering parameters.

Event Description

The hospital representative, mr (b)(6) states, "there ws an accidental vascular injury in an aneurysm surgery with the current micro doppler probes, which are no longer completely encased in a round-ended atraumatic plastic sheath, including the probe tip, but are encased in a relatively sharp-edged, cylindrical-ended plastic sheath".Addition infromation provided on 03-aug-2020 - the injured vessel was coagulated".So injury occured but coagulated and patient is fine.

• Brand Name: MIZUHO DISPOSABLE DOPPLER PROBE FOR NEUROSURGERY
• Type of Device: DOPPLER PROBE
• Manufacturer (Section D): VASCULAR TECHNOLOGY INCORPORATED,; 12 murphy drive; nashua, nh
• Manufacturer (Section G): VASCULAR TECHNOLOGY INCORPORATED; 12 murphy drive; nashua, nh
• Manufacturer Contact: david regan ; 12 murphy drive; nashua, nh ; 5949700222
• MDR Report Key: 10384823
• MDR Text Key: 204275464
• Report Number: 1221072-2020-00001
• Device Sequence Number: 1
• Product Code: DPW
• UDI-Device Identifier: 00817122020201
• UDI-Public: (01)00817122020201
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2021
• Device Model Number: 07-150-10
• Device Catalogue Number: 138660
• Device Lot Number: 16051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 08/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1