MAUDE Adverse Event Report: COOK VANDERGRIFT INC COOK-SWARTZ DOPPLER PROBE; DIAGNOSTIC ULTRASONIC TRANSDUCER

Catalog Number DP-SDP001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Product code: itx.Implant date, explant date: exact dates of implant and explant of the complaint device are unknown as the literature provided only indicates that the doppler cuff was implanted in the patient for 180days before being surgically removed due to infection pma/510(k): k171272.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available or upon completion of investigation.

Event Description

As reported in the literature findings "a patient underwent hemi glossectomy for squamous cell carcinoma of the right lateral tongue followed by reconstruction with a tissue flap.A cook-swartz implantable doppler (cook-swartz doppler flow probe dp-sdp001) was placed using a ligature clip to secure its probe cuff around the pedicle of the cephalic vein, and recovery was uneventful.[however,] six months after placement, the patient reported pain that did not resolve with antibiotic treatment, and ultrasound revealed a foreign body in the right submandibular region.The probe cuff and ligature clips were removed, and they were surrounded by reactionary granulomatous tissue.Removal of the device resolved the pain".Although the doppler flow probe was removed from the patient after 7days, as advised in the manufacturer's instructions for use, the doppler cuff and attaching ligature clips are intended to be left implanted in the patient.The adverse event sited in this literature finding is indicated to be discomfort caused by an infection which formed around the doppler cuff and ligature clips which "resolved swiftly" once they were surgically removed from the patient.No other consequences to the patient have been reported as occurring.At this time, no additional information is available.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.The article identifies the cuff as the source of the infection and inflammation and is constructed of expanded polytetrafluoroethylene (eptfe).This is incorrect.The cuff is constructed of nusil med-4750 silicone.Additional information: h6- ec method code desc - 1: device not returned (4114), h6- ec results code desc - 1: no findings available (3221), h6- ec conclusions code desc - 1: known inherent risk of device (22), h10- added summary of investigation.Investigation-evaluation: as per journal article: postoperative neck pain associated with an implantable microvascular ultrasonic doppler: a case report:: the incidence of cancers in the head and neck is on the rise.Despite advances in chemoradiotherapy, operation remains a chief strategy of management.The primary complication associated with reconstruction using microvascular free flaps is thrombotic occlusion of the vessels, which is reported to account for failure in 10% of cases.As most flaps fail within the first 48 hours, prompt identification facilitates early salvage and improved outcomes.Monitoring perfusion is both demanding and technique sensitive, and the challenge is compounded when the flap is buried, which makes assessment difficult.Many studies have reinforced the role of the cook-swartz doppler in improving outcomes after free flaps, and to our knowledge, no adverse complications have been published to date."a patient underwent hemi glossectomy for squamous cell carcinoma of the right lateral tongue followed by reconstruction with a tissue flap.A cook-swartz implantable doppler was placed using a ligature clip to secure its probe cuff around the pedicle of the cephalic vein, and recovery was uneventful.Six months after placement, the patient reported pain that did not resolve with antibiotic treatment, and ultrasound revealed a foreign body in the right submandibular region.The probe cuff and ligature clips were removed, and they were surrounded by reactionary granulomatous tissue.Removal of the device resolved the pain".Per ifu (d00078672 rev003): "caution: do not remove the probe conductor wire and crystal assembly (leaving only the cuff in situ on the vessel), until vessel monitoring is completed (commonly 3-5 days).Probe conductor wire and crystal assembly placement must not exceed 29 days.Cuff alone may remain within the patient indefinitely.", "use of the cook-swartz doppler flow probe involves potential risks normally associated with any implanted device, e.G., infection, perforation or laceration of vessels, erosion, implant rejection, or device dislodgement/migration." this report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

As per source doc: "a patient underwent hemi glossectomy for squamous cell carcinoma of the right lateral tongue followed by reconstruction with a tissue flap.A cook-swartz implantable doppler was placed using a ligature clip to secure its probe cuff around the pedicle of the cephalic vein, and recovery was uneventful (page 265).Six months after placement, the patient reported pain that did not resolve with antibiotic treatment, and ultrasound revealed a foreign body in the right submandibular region (page 265).The probe cuff and ligature clips were removed, and they were surrounded by reactionary granulomatous tissue (page 266).Removal of the device resolved the pain".

• Brand Name: COOK-SWARTZ DOPPLER PROBE
• Type of Device: DIAGNOSTIC ULTRASONIC TRANSDUCER
• Manufacturer (Section D): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 9176717
• MDR Text Key: 168027479
• Report Number: 2522007-2019-00018
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

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 Catalogue Number: DP-SDP001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/12/2019
• Initial Date FDA Received: 10/10/2019
• Supplement Dates Manufacturer Received: 09/12/2019
• Supplement Dates FDA Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR