MAUDE Adverse Event Report: XERIDIEM MEDICAL DEVICES ENDOVIVE STANDARD BALLOON REPLACEMENT KIT; GASTROSTOMY TUBE

Model Number 70-0024-024

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

No patient information is available beyond what is listed for sex.Exact dates of death or the event are not known.Model number is xeridiem part number for the device.Catalog number is part number for xeridiem's exclusive distributor for the device, boston scientific.Since lot number is not available, full udi and expiration date are unknown.Devices were not returned for evaluation.Since lot number is not available, manufacturing date cannot be determined.Patient code and device codes reflect what was reported for the complaint.Other codes are chosen based on devices not being returned for evaluation.

Event Description

Patient's wife reported that in a span of 8 days, 4 of the peg tubes malfunctioned on her husband.The balloon deflated, dumped all of his stomach acid and his stomach contents into his abdomen causing peritonitis; he died in three days.The caller had documented the balloon's malfunction.She had witnessed one, before they inserted the fourth tube, they have tested one and it would not hold, it had holes on the balloon.After her husband died, she did not ask the funeral home to cut the tube out of him so she could have it in her hands.The original physician that put the tube in was dr.(b)(6).The physicians that were also consulted were (b)(6).(b)(6) was the gastric doctor that when he looked at the cat scan and said that they needed to call general surgery to open him up.(b)(6) took him to surgery and cleaned him out.Dr.(b)(6) was the one to put the second one in.The very next morning, dr.(b)(6) found that the tube had malfunctioned again and did the next tube.

• Brand Name: ENDOVIVE STANDARD BALLOON REPLACEMENT KIT
• Type of Device: GASTROSTOMY TUBE
• Manufacturer (Section D): XERIDIEM MEDICAL DEVICES; 4700 s. overland drive; tucson AZ 85714 3430
• Manufacturer (Section G): XERIDIEM MEDICAL DEVICES; 4700 s. overland drive; tucson AZ 85714 3430
• Manufacturer Contact: steve murray ; 4700 s. overland drive; tucson, AZ 85714-3430 ; 5208827794
• MDR Report Key: 7523479
• MDR Text Key: 108566295
• Report Number: 2025851-2018-00003
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70-0024-024
• Device Catalogue Number: M00582090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death