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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK VASCULAR INC COOK-SWARTZ DOPPLER PROBE

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COOK VASCULAR INC COOK-SWARTZ DOPPLER PROBE Back to Search Results
Model Number N/A
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Manufacturer Narrative
Investigation/evaluation: complaint was confirmed via customer testimony. Review of device history record was unable to be performed as the lot number of the involved device is unknown. Root cause is unable to be determined as the necessary information to adequately investigate the reported event was not provided. A summary of the investigation has been sent to the complainant. Device not returned for evaluation.
 
Manufacturer Narrative
(b)(4). The event is currently under investigation. A follow up will be generated upon the completion of the investigation.
 
Event Description
The customer reported experiencing difficulty with removing the cook-swartz doppler probe from the doppler cuff. It was reportedly more difficult than normal to pull the probe from the cuff. Additionally, while the probe was being pulled from the patient, the wire of the device frayed and broke off mid-length. The break was reportedly attributed to excessive wire length in the patient's abdomen, which wrapped the bowel, placed excessive strain on the wire, and resulted in a wire fracture. The wire was left inside the patient. The ifu for the cook-swartz doppler flow probe states in the precautions section and the instructions for use section the following actions to take if difficulty removing the probe occurs: precautions: avoid use of excessive force to remove the transducer assembly from the patient, which may cause injury to the blood vessel. If the transducer assembly can not be removed using gentle traction, the transducer assembly should be removed surgically. Instructions for use: upon removal of the cook-swartz doppler flow probe, examine the distal tip of the probe to ensure that the transducer assembly is present. In the unlikely event that the transducer assembly has become detached and remains in the cuff in the patient, the transducer assembly should be removed surgically.
 
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Brand NameCOOK-SWARTZ DOPPLER PROBE
Manufacturer (Section D)
COOK VASCULAR INC
1186 montgomery lane
vandergrift PA 15690
Manufacturer Contact
brian johnston
1186 montgomery lane
vandergrift, PA 15690
MDR Report Key6590192
MDR Text Key197201397
Report Number2522007-2017-00022
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K022649
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberDP-SDP001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/25/2017 Patient Sequence Number: 1
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