MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES B3855, SILH XTRAFLO URTL STENT 6FX22CM; STENT, URETERAL

Model Number B3855

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 01/14/2020

Event Type  Injury  

Manufacturer Narrative

No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A follow up report will be sent once the results have been analyzed.

Event Description

Patient procedure: "stent implanted (b)(6) 2019, cysto stent placement" "while at home, patient spontaneously had ureter stent dislodge and fall out when urinating.The upper coil is still in the body." "will have surgery again." intervention: patient requires a second surgery.Patient status: "will have surgery again.".

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.However, photos of the event unit were provided by the complainant.Based on the photos, a portion of the stent had separated from the rest of the stent body.Images of the separated coil were not provided.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

Event Description

Patient procedure: "stent implanted on (b)(6) 2019, cysto stent placement".Detailed description of event: "while at home, patient spontaneously had ureter stent dislodge and fall out when urinating.The upper coil is still in the body." "will have surgery again".Product is not available for return.Additional information received via phone on (b)(6) 2020 from [name].The green sheathing below the metal tip of the stent was what fell out of the patient.The tip remained in the patient's bladder.The second surgery was last week, the portion of the stent that was still in the patient was removed at that time and a new stent was placed.The patient already required a second surgery as treatment for their disease.The removal of the broken stent was an step added to this surgery as a result of this event.Patient is doing well, with no complaints or complications.No patient injury.The portion of the stent that was removed from the bladder has been sent to pathology for examination.An internal incident report (midas) has been created at fox chase cancer center and legal has been notified.The facility is planning to submit a medwatch report for this event.[name] is currently in possession of the part of the stent that fell out of the patient and once pathology is finished with their examination, she expects to receive the tip as well.[name] does not feel comfortable sending the product back to applied medical for investigation at this time.Additional information received via email on 10mar2020 from [name].Five pictures of the device have been sent.Additional information received via phone on 10mar2020 from [name].The facility is experienced with using this device.Additional information received via email on 26may2020 from [name]."the correct history is the stent fractured closer to the kidney, near the upper curl, and the lower portion (about 2/3 of the stent) spontaneously came out of the patient.The upper portion was confirmed still in normal position (held in place by the upper curl) and it was in the upper ureter and kidney.That was subsequently removed and the stent was replaced on feb 19." patient status: the patient required a second surgery to treat their disease.Type of intervention: the patient already required a second surgery as treatment for their disease.The removal of the broken stent was an step added to this surgery as a result of this event.

• Brand Name: B3855, SILH XTRAFLO URTL STENT 6FX22CM
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9735457
• MDR Text Key: 182327508
• Report Number: 2027111-2020-00371
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00607915112455
• UDI-Public: (01)00607915112455(17)210829(30)01(10)1335215
• Combination Product (y/n): N
• PMA/PMN Number: K040760
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/30/2020

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 Expiration Date: 08/29/2021
• Device Model Number: B3855
• Device Catalogue Number: 100964607
• Device Lot Number: 1335215
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/22/2020
• Initial Date FDA Received: 02/20/2020
• Supplement Dates Manufacturer Received: 01/22/2020
• Supplement Dates FDA Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention