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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRACLIP DUAL TRIGGER BREAST TISSUE MARKER

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BARD PERIPHERAL VASCULAR, INC. ULTRACLIP DUAL TRIGGER BREAST TISSUE MARKER Back to Search Results
Catalog Number UNK ULTRACLIP DT
Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer. The lot number for the device was not provided. The device has not been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported that post marker placement the patient experienced pain in her arm. The marker remains implanted. No treatment information was provided. The current patient status is unknown.
 
Manufacturer Narrative
Manufacturing review: a complete manufacturing review could not be performed, as the lot number is unknown. Visual/microscopic inspection: as the device was not returned, an inspection could not be performed. Functional/performance evaluation: as the device was not returned, an evaluation could not be performed. Medical records review: as medical records were not provided, a review could not be performed. Image/photo review: no medical images have been made available to the manufacturer. Conclusion: the investigation is inconclusive, as the sample was not returned for evaluation. The definitive root cause could not be determined based upon available information. It is unknown whether procedural issues contributed to the event. Labeling review: instructions for use (ifu): pk4320200 rev 0 that was included in the product prescribes the proper method of implantation for this device to prevent undue injury to the patient and damage to the product. The ultraclip® dual trigger device is supplied sterile and non-pyrogenic unless the package has been opened or damaged. Sterilized by using ethylene oxide. For single use only. Do not reuse. Do not resterilize. Indications for use: the ultraclip® dual trigger breast tissue marker is intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure. Contraindications for use: this device is not intended for use except as indicated above. Potential complications: potential complications of marker placement may consist of hematoma, hemorrhage, infection, adjacent tissue injury and pain. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
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Brand NameULTRACLIP DUAL TRIGGER BREAST TISSUE MARKER
Type of DeviceBREAST TISSUE MARKER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 west 3rd st.
tempe AZ 85281
Manufacturer (Section G)
BARD SHANNON LIMITED
san geronimo industrial park
lot #1, road #3, km 79.7
humacao 00791
Manufacturer Contact
judith ludwig
1625 west 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key5396553
MDR Text Key37531183
Report Number2020394-2016-00134
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090547
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/29/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK ULTRACLIP DT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/07/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 01/28/2016 Patient Sequence Number: 1
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