MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX; CLIP, IMPLANTABLE

Model Number CA500

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Injury (2348)

Event Date 03/11/2019

Event Type  Injury  

Manufacturer Narrative

No product is being returned for evaluation and no lot # has been provided to manufacturer.A follow up report will be sent once the results have been analyzed.

Event Description

Procedure performed: lap chole.24 hours following procedure, patient returned with bile leak.Doctor said it was from a small bile radical duct that he applied a clip to during the initial lap chole.When patient returned to theatre, on call surgeon performed wash out and re-clipped.Doctor said the previous clip applied to small bile radical duct was not present when on call surgeon re-operated.Doctor said he suspects that when the on call surgeon reapplied the clip, the clip may not have been applied in correct place as it would have been very difficult to locate the small bile radical duct.Doctor said that clips (from epix clip applier) were intact on main cystic duct and cystic artery.Following this surgery, bile leak continued and patient returned to theatre for ercp.Once completed, patient was discharged additional information received via email from team member, 21may2019: the event took place on days following (b)(6) 2019 but doctor only informed me today when i saw him.I was present during the case on (b)(6) when ca500 was used but there were no problems reported at the time.Additional information received from applied medical representative, 17jun2019: the epix universal clip applier, mod.Ca500, was not used in the second procedure.

Manufacturer Narrative

Investigation summary: the event unit was not returned to applied medical for evaluation, and the lot number was not provided.As the event unit was not returned, testing was unable to be performed and the complainant¿s experience could not be replicated or confirmed.In the absence of the event unit, it is difficult to determine the exact root cause of the event.Applied medical has reviewed the details surrounding the event and related products.At this time, applied medical is unable to determine the cause of the injury or confirm that a product malfunction occurred.

Event Description

Procedure performed: lap chole.24 hours following procedure, patient returned with bile leak.Doctor said it was from a small bile radical duct that he applied a clip to during the initial lap chole.When patient returned to theatre, on call surgeon performed wash out and re-clipped.Doctor said the previous clip applied to small bile radical duct was not present when on call surgeon re-operated.Doctor said he suspects that when the on call surgeon reapplied the clip, the clip may not have been applied in correct place as it would have been very difficult to locate the small bile radical duct.Doctor said that clips (from epix clip applier) were intact on main cystic duct and cystic artery.Following this surgery, bile leak continued and patient returned to theatre for ercp.Once completed, patient was discharged additional information received via email from team member, 21may2019: the event took place on days following (b)(6) 2019 but doctor only informed me today when i saw him.I was present during the case on (b)(6) when ca500 was used but there were no problems reported at the time.Additional information received from applied medical representative, 17jun2019: the epix universal clip applier, mod.Ca500, was not used in the second procedure additional information received from applied medical representative, 25jun2019: the patient was discharged following the third (ercp) procedure.Patient status: patient returned to theatre twice due to continued bile leak.Patient was discharged after third procedure.

• Brand Name: CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8708398
• MDR Text Key: 148314293
• Report Number: 2027111-2019-00478
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K011236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CA500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/21/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization