MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN_INSTRUMENTS_PRODUCT; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number UNK_INS

Device Problem Failure to Power Up (1476)

Patient Problem Death (1802)

Event Date 04/21/2016

Event Type  Death  

Manufacturer Narrative

Device not returned to manufacturer for evaluation.

Event Description

It was reported through litigation that during a cardiac ablation surgery a transseptal catheterization was performed.The complaint alleges that the surgeon claims that the mapping documented the ablation catheter to be anterior, but near the left atrium.The plaintiff alleges that the mapping of the catheter was off and the surgeon later determined that the catheter was likely in the aortic root.It is alleged that the transseptal catheter transversed the right atrium into the aorta and punctured the aorta and the intravascular ultrasound catheter documented evidence of pericardia effusion.The complaint alleges that the catheter was removed, and the pericardium started to fill up with fluid.The plaintiff alleges an emergency pericardiocentesis was performed to remove fluid that was aspirated from the pericardium.It is alleged that a second pericardiocentesis was performed.The complaint alleges that a code blue was called over 44 minutes after the initial puncture to summon the equipment necessary to open the patient¿s chest.The plaintiff alleges that the patient¿s blood pressure continued decreasing.It is alleged that a call was made for a cardiac surgeon 2 minutes after the code blue.The complaint alleges that despite cpr, the patient¿s systolic blood pressure plummeted to 50 and remained at 50 or less for over 20 minutes.The plaintiff alleged that during the sternotomy procedure, three sternal saw batteries were depleted or defective.It is alleged that with a fourth battery, the emergency sternotomy procedure was performed about an hour after the initial puncture.The complaint alleges that after the procedure, the patient remained in a coma and was eventually diagnosed with anoxic encephalopathy.The plaintiff alleges that the patient never regained consciousness and after more than a week died.

• Brand Name: UNKNOWN_INSTRUMENTS_PRODUCT
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6755583
• MDR Text Key: 81462061
• Report Number: 0001811755-2017-01706
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/31/2017

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_INS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2017
• Initial Date FDA Received: 07/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 52 YR