MAUDE Adverse Event Report: BALT USA, LLC OPTIMA COIL SYSTEM

Model Number OPTI0620CST10

Device Problem Device Slipped (1584)

Patient Problem Aneurysm (1708)

Event Date 03/17/2020

Event Type  malfunction  

Manufacturer Narrative

To whom it may concern: on (b)(6) 2020, balt usa received a complaint regarding the use of a single optima coil (6mm x 20cm complex standard coil).Details reported as follows: "the coil was ruptured during insertion process.Part of that was left in aneurysm and the res - out of the aneurysm.Patient got open surgery to remove the residual parts." the results of our investigation, are summarized as follows: -balt usa has made four separate attempts to follow up with the customer regarding patient status and procedure details, with no customer response.-an evaluation of the actual complaint sample could not be performed device was reported unavailable.Root cause could not be definitively determined.Lack of additional information and device return prevented deeper evaluation of the reported issue.Review of the lot history records for the reported lots did not reveal any in-process or lot-specific issue that could account for the observation.No additional complaints against lot number 060319a has been made for the same issue.Comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.

Event Description

It was reported that: "the coil was ruptured during insertion process.Part of that was left in aneurysm and the res - out of the aneurysm.Patient got open surgery to remove the residual parts.".

Manufacturer Narrative

To whom it may concern: on march 23th, 2020, balt usa received a complaint regarding the use of a single optima coil (6mm x 20cm complex standard coil).Details reported as follows: "the coil was ruptured during insertion process.Part of that was left in aneurysm and the res - out of the aneurysm.Patient got open surgery to remove the residual parts." follow up was done periodically with the customer.Details reported as follows: the issue was, that the coil was ruptured - the part of it stayed in the aneurysm, but the other part - was out of the aneurysm.Meaning, it was ruptured during insertion and it was not possible to insert it into aneurysm, or to remove it.After multiple tries, to remove the coil, the aneurysm got ruptured.Patient has got an open surgery and is in still in critical condition.The coil has ruptured during insertion - the distal part remained partially in aneurysm and partially - in the parent vessel, while the proximal part (of the coil itself) remained attached to the delivery part (pusher) and was extracted out of the vessel.-the aneurysm has ruptured during the procedure.-most likely, the aneurysm did not rupture because of the coil, but after multiple tries to extract it out.The results of our investigation, are summarized as follows: balt usa has made four separate attempts to follow up with the customer regarding patient status and procedure details, with no customer response.An evaluation of the actual complaint sample could not be performed device was reported unavailable.Root cause could not be definitively determined.Lack of additional information and device return prevented deeper evaluation of the reported issue.Review of the lot history records for the reported lots did not reveal any in-process or lot-specific issue that could account for the observation.No additional complaints against lot number 060319a has been made for the same issue.Comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.The submission of this report or related information to the fda, and its release by fda, does not reflect a conclusion by the party submitting this report of the fda that the report or related information is an admission that the manufacturer, their employees, or the device caused or contributed to the reportable event.

Event Description

It was reported that: "the coil was ruptured during insertion process.Part of that was left in aneurysm and the res - out of the aneurysm.Patient got open surgery to remove the residual parts.".

• Brand Name: OPTIMA COIL SYSTEM
• Type of Device: OPTIMA
• Manufacturer (Section D): BALT USA, LLC; 29 parker; irvine, ca
• MDR Report Key: 9975410
• MDR Text Key: 191987973
• Report Number: 3014162263-2020-00010
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00818053026324
• UDI-Public: 00818053026324
• Combination Product (y/n): N
• PMA/PMN Number: K172390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: OPTI0620CST10
• Device Catalogue Number: N/A
• Device Lot Number: 060319A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention