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

Model Number G21363

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem Perforation of Vessels (2135)

Event Date 01/27/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4). Pma/510(k): k171272. (b)(4). The event is currently under investigation. A follow up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

As reported to customer relations via complaint form "we have had many wires break off when pulling them out over the past few months. We typically pull the wires on pod5-7 and did not have issues but recently, they are extremely hard to pull out and break off proximal to the doppler itself. This led to a practice change that the wire would be cut with a tail external to the patient and pulled out two weeks later in clinic. The hospital required another practice change as they considered that a retained foreign body. Therefore, my partner pulled this one and again, had significant resistance and the wire broke. This caused an arterial injury on an otherwise viable flap on pod 5-7. The flap ultimately required revision twice and has now failed. There is no doubt it was related to the trauma caused by the wire. ".

• Brand Name: COOK-SWARTZ DOPPLER PROBE
• Type of Device: DIAGNOSTIC ULTRASONIC TRANSDUCER
• Manufacturer (Section D): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer (Section G): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer Contact: brian johnston ; 1186 montgomery lane; vandergrift, PA 15690 ; 7248458621
• MDR Report Key: 11359799
• MDR Text Key: 242049116
• Report Number: 2522007-2021-00008
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: G21363
• Device Catalogue Number: DP-SDP001
• Device Lot Number: N172375
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/22/2021 Patient Sequence Number: 1