MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Death (1802)

Event Date 05/01/2013

Event Type  Death  

Manufacturer Narrative

(b)(4).It was reported that an autopsy was not performed.The baxter healthcare corporation product is no longer suspect in this report.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).It was reported that a patient had an unknown medical procedure performed and subsequently died.The patient had started an unknown treatment approximately nine months and one week prior to death at a clinic for an unreported indication.The dates and type of treatment were not reported.The cause of death was not reported.It was not reported if the patient was hospitalized prior to death.It was not reported if an autopsy was performed.No additional information is available.

Manufacturer Narrative

(b)(4).The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient died while using unspecified biosurgery products.The reporter stated ¿defective (unspecified) endovascular graft deployment systems, delivery systems, balloons, wires, catheters and accompanying equipment" (no further detail was provided).It was reported, unspecified biosurgery products were in use at the time of death.Starting approximately nine months and a week prior to death, on unspecified date(s), the patient received unspecified treatment at a clinic for an unreported indication.The cause of death was not reported.It was not reported if the patient was hospitalized prior to death.It was not reported if an autopsy was performed.No additional information is available.

Manufacturer Narrative

(b)(4).The patient was treated at a clinic between (b)(6) 2012 and (b)(6) 2013.Should additional relevant information become available, a supplemental report will be submitted.

• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4804954
• MDR Text Key: 14032007
• Report Number: 1416980-2015-23349
• Device Sequence Number: 1
• Product Code: DWS
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/06/2015

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/26/2015
• Initial Date FDA Received: 05/29/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/03/2015; 06/09/2015; 07/20/2015
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 76 YR
• Patient Weight: 66