MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR CANISTER

Catalog Number SCCAN01

Device Problem Suction Problem (2170)

Patient Problem Hematoma (1884)

Event Date 07/02/2015

Event Type  Injury  

Manufacturer Narrative

A manufacturing review could not be performed as the lot number is unknown.The sample is not available for return; therefore, an evaluation of the device could not be performed.The investigation 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 during a stereotactic breast biopsy, after several attempts and restarting the system the canister was unable to obtain suction.Another canister was used and was not able to obtain suction.The procedure was completed with a different device.A hematoma formed at the biopsy site and additional pressure was required.The patient was discharged and additional time is expected for the hematoma to resolve.

Manufacturer Narrative

This event was previously reported in the initial mdr report as a serious injury mdr.After further review of the event details and communication with bard medical group, it was determined that application of addition pressure would not constitute medical intervention or treatment; therefore, the reportability of this event has been changed to not reportable.Since an initial mdr was submitted, this follow up report will be submitted with the results of the complaint investigation.Manufacturing review: a manufacturing review could not be performed, as the lot number was not provided.Visual/microscopic inspection: none - no sample returned.Functional/performance evaluation: none - no sample returned.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 patient and/or procedural issues contributed to the event.Labeling review: the current enspire instructions for use (ifu) states: precautions: - inspect tubing connections to the vacuum canister and the vacuum tubing cassette to ensure proper vacuum levels are achieved and maintained during use.- inspect the vacuum canister to ensure the lid is secure and that no damage has occurred during shipping or installation.A heavily scratched canister can break during use.

• Brand Name: ENCOR CANISTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BEMIS DRUG; 6 brighton st; no abington MA 02351
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 4992191
• MDR Text Key: 22653199
• Report Number: 2020394-2015-01305
• Device Sequence Number: 1
• Product Code: GCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/02/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SCCAN01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2015
• 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 Sequence Number: 1
• Treatment: ENCOR BIOPSY PROBE
• Patient Outcome(s): Required Intervention