PERCUTANEOUS SHEATH INTRODUCER KIT AK-09800

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-05 for PERCUTANEOUS SHEATH INTRODUCER KIT AK-09800 manufactured by Arrow International.

Event Text Entries

[1237] The patient was a 61 year old female admitted with metabolic encephalopathy with dehydration. History of copd, alcoholism, peripheral neuropathy. Work-up demonstrated gastric ulcer with evidence of erosive gastroduodenitis. Admitted to icu with placement of swan ganz catheter with introducer kit on november 7th, 1992. Was receiving iv fluids via side port of swan ganz catheter. During early morning hours of nov. 11, 1992 patient apparently got out of bed unassisted, at some point disconnected iv tubing and fell. Patient experienced significant blood loss via side port of swan ganz. Patient went into cardiac arrest and subsequently died. Final diagnosis hypovollemic shock-seconday massive blood lossdevice labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: a device from same lot was evaluated, visual examination. Results of evaluation: design. Conclusion: device discarded - unable to follow-up, other. Certainty of device as cause of or contributor to event: yes. Corrective actions: device discarded, user education provided, other. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2069
• MDR Report Key: 2069
• Date Received: 1993-01-05
• Date of Report: 1992-12-12
• Date of Event: 1992-11-11
• Date Facility Aware: 1992-11-11
• Report Date: 1992-12-12
• Date Reported to FDA: 1992-12-12
• Date Reported to Mfgr: 1992-11-23
• Date Added to Maude: 1993-01-08
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PERCUTANEOUS SHEATH INTRODUCER KIT
• Product Code: EYT
• Date Received: 1993-01-05
• Model Number: AK-09800
• Catalog Number: AK-09800
• Lot Number: AK-9-183-1
• ID Number: DIN 00815357
• Operator: OTHER CAREGIVERS
• Device Availability: N
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 1915
• Manufacturer: ARROW INTERNATIONAL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1993-01-05