MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number OPTI0308CSS10

Device Problems Detachment of Device or Device Component (2907); Unintended Movement (3026)

Patient Problem Aneurysm (1708)

Event Date 08/30/2020

Event Type  malfunction  

Manufacturer Narrative

Balt usa's reference number: (b)(4).To whom it may concern: on (b)(6) 2020, balt usa has been notified of an event regarding the use of a single optima coil.Details reported as follows: during coiling procedure of a pcom anx, the physician began delivering a 3x8 css10 coil.This was the fourth coil of the case starting with a 4x7csfmx, 3x10css10, and 3x8css10.The physician was able to deliver approxomately 75% of the coil, however, the last couple cms kept pushing the microcatheter out of the anx.The physician attempted to reposition the coil multiple times over aprroximately 15 minutes with no success.While removing the coil, the physician felt a slight hitch prompting to believe the coil detached.Only a couple cm remained in the mc so shen the physician tried removing both the coil and the mc, the coil released from the tip of the mc and flowed distal to the anx but was still anchored within the coil mass.The physician was able to lasso the coil and remove the coil completely with no adverse events.We then continued coiling the anx successfully and was pleased with the results.The returned device was inspected in our quality laboratory.During our analysis: we noted that two separate returns for this rga was made.One return consisted of seven delivery pusher and other consisted of one delivery pusher and one implant; we noted that with the first return (7 delivery pushers), 5 of the delivery pusher appeared to have detached through a normal detachment sequence with an xcel detachment controller.The other two delivery pusher appeared as if no detachment sequence was ran; we noted that with the second return (1 delivery pusher + 1 implant), the delivery pusher appeared as if no detachment sequence was ran; we observed the implant to be stretched on its proximal end; we observed the sr thread sticking out of the implant's proximal end.The sr thread appeared opaque in color usually meaning a slow stretch of the thread took place until it snapped; we noted that the implant was no longer able to fully take its heat-set shape.It is unknown if this due to manipulation the implant endured or not.Root cause cannot be determined as it is unknown why the last few centimeters of the coil caused the microcatheter to kick out of the aneurysm.It is possible the that implant had trouble conforming to its heat-set shape; however, this cannot be confirmed as its lost of ability to fully take its heat-shape could be due to the manipulation and retrieval of the implant.The premature detachment was most likely due to the proximal end of the implant getting caught on other devices at the treatment site.During manipulation the sr thread was stretched until it snapped.Review of the lot history records did not reveal any in-process or lot-specific issue that could account for the observation.No additional complaints against lot number f191100165 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: during coiling procedure of a pcom anx, the physician began delivering a 3x8 css10 coil.This was the fourth coil of the case starting with a 4x7csfmx, 3x10css10, and 3x8css10.The physician was able to deliver approximately 75% of the coil, however, the last couple cms kept pushing the microcatheter out of the anx.The physician attempted to reposition the coil multiple times over approximately 15 minutes with no success.While removing the coil, the physician felt a slight hitch prompting to believe the coil detached.Only a couple cm remained in the mc so shen the physician tried removing both the coil and the mc, the coil released from the tip of the mc and flowed distal to the anx but was still anchored within the coil mass.The physician was able to lasso the coil and remove the coil completely with no adverse events.We then continued coiling the anx successfully and was pleased with the results.

• Brand Name: OPTIMA COIL SYSTEM
• Type of Device: OPTIMA
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• Manufacturer Contact: moises colin ; 29 parker; irvine 92618
• MDR Report Key: 10570826
• MDR Text Key: 214329767
• Report Number: 3014162263-2020-00024
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00818053021541
• UDI-Public: 00818053021541
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2021
• Device Model Number: OPTI0308CSS10
• Device Catalogue Number: N/A
• Device Lot Number: F191100165
• Date Manufacturer Received: 08/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention