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 Problems Injury (2348); Blood Loss (2597)

Event Date 10/10/2020

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.A laparoscopic cholecystectomy was performed on (b)(6) 2020 where two epix clips were applied to the cystic artery.On (b)(6) 2020 the patient returned to the or for intra-abdominal bleeding and it was found that both clips were floating freely in the abdomen and the cystic artery was actively bleeding.A diagnostic laparoscopy/exploratory laparotomy with control of bleed was performed.The patient is currently inpatient.Additional information was received via telephone on 16oct2020 from acct.Mgr.Nine hours after the surgery the patient's vitals dropped and the surgeon had to open the patient to control the bleed.The surgeon and staff did not attribute the device's function to the patient's condition post-operatively.The surgeon continues to use the clip applier for subsequent cases.The gallbladder was reported as 'dead'.No other co-morbidities were known.The clips were removed from the patient and were discarded.The event device was discarded by the hospital after the case.The lot number is unknown.Additional information was received via telephone on 19oct2020 from acct.Mgr.The acct.Mgr.Spoke with the or director.The patient had surgery on (b)(6) 2020 and was released home (b)(6) 2020 after having surgery to control the bleed and two blood transfusions.Photos of the clips placed on the duct after the surgery are available.Patient status: the patient is currently inpatient.Intervention: a diagnostic laparoscopy/exploratory laparotomy with control of bleed was performed.

Event Description

Procedure performed: lap chole.A laparoscopic cholecystectomy was performed on (b)(6) 2020 where two epix clips were applied to the cystic artery.On (b)(6) 2020 the patient returned to the or for intra-abdominal bleeding and it was found that both clips were floating freely in the abdomen and the cystic artery was actively bleeding.A diagnostic laparoscopy/exploratory laparotomy with control of bleed was performed.The patient is currently inpatient.Additional information was received via telephone on 16oct2020 from acct.Mgr.Nine hours after the surgery the patient's vitals dropped and the surgeon had to open the patient to control the bleed.The surgeon and staff did not attribute the device's function to the patient's condition post-operatively.The surgeon continues to use the applied clip applier for subsequent cases.The gallbladder was reported as "dead".No other co-morbidities were known.The clips were removed from the patient and were discarded.The event device was discarded by the hospital after the case.The lot number is unknown.Additional information was received via telephone on 19oct2020 from acct.Mgr.The acct.Mgr.Spoke with the or director.The patient had surgery on (b)(6) 2020 and was released home (b)(6) 2020 after having surgery to control the bleed and two blood transfusions.Photos of the clips placed on the duct after the surgery are available.Additional information was received via telephone on 26oct2020 from acct.Mgr.Photos of the clips placed on the duct after the surgery were provided.Event date is (b)(6) 2020.Patient status: the patient is currently inpatient.Intervention: a diagnostic laparoscopy/exploratory laparotomy with control of bleed was performed.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation, and the lot number was not provided.A photo of the clip placement was provided; however, the complainant¿s experience could not be confirmed as the photo was taken after the initial surgery was performed.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 if the reported event was caused by a device non-conformance.Applied medical has reviewed the details surrounding the event and related product and is unable to determine the exact root cause of the reported event.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical is currently researching possible enhancements intended to further minimize the potential for this type of event to occur.

• 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: 10744590
• MDR Text Key: 213415925
• Report Number: 2027111-2020-00589
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CA500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization