MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number OPTI0930CST10

Device Problems Break (1069); Separation Failure (2547); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2020

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: "the physician was doing a venous embo of a davf where he was coiling off the transverse sinus.His 37th coil was a 9x30 complex standard.The catheter had lots of forward tension and he was packing in a tight spot.He attempted to detach and the coil didn't release after first cycle.He tried a second cycle and xcel was giving christmas tree lights and the coil didn't detach.He tried a third time and pushed the coil and pusher well past the proximal line and it still didn't pop off the pusher.He tried detaching a fourth time.He then tried to remove the coil and it was lodged in the coil mass.He pulled until the coil broke and separted.The coil and pusher stretched as he removed.He then had to remove the catheter and there was coil and pusher stretched out of the sheath.He pulled and broke off more of the coil and pusher.He had to remove the sheath because there was coil and pusher down the sheath.He pulled another segment of coil out until it broke.He placed another sheath and catheter and was able to finish the case without harm to the patient.He used 10 more optimas without any incident." follow up (08-oct-2020) "he initially pulled on the coil until it snapped.The piece was taken out.He then removed the catheter and another piece was pulled on until it snapped.He then had to remove the guide and pulled on a piece that was hanging out of the guide until it broke off.He tried to use a stent to retrieve the coil out of the sheath but it wouldn't move because the distal portion of the coil remaining was still tangled in the coil mass." the returned device was inspected in our quality laboratory.During our analysis: we observed two whole delivery pusher stretched and tangled together.In mix of entanglement, another pusher' distal half was found; however, its proximal half could not be located; detachment zone (1): appeared as if a normal detachment sequence took place using an xcel detachment controller.A 90¿ kink was observed just proximal of the detachment zone.Detachment zone (2): observed to be clean, no indication of a detachment sequence being ran.Sr thread was observed sticking out of a few mm past the detachment zone.Proximal end of the sr thread was opaque and distal end was clear and bent about 90¿.Sr thread appeared torn.Detachment zone (3): appeared as if a normal detachment sequence took place using an xcel detachment controller; however, was completely damaged and kinked.We noted that no coil or broken pieces of coil were returned ; we noted that the microcatheter and guide were returned.The two devices flushed with no pieces of the broken coil found within.Root cause for the detachment issue cannot be determined.Solder joints of the lead wires on the second detachment zone look intact.Without return of the xcel unit, a definitive conclusion cannot be made.However, the stretching of and break of the coil most likely took place due to the implant get caught with other devices at the treatment.During retrieval of the delivery system the sr thread experienced a force greater than its tensile strength and snapped.Without a return of the implant we cannot fully conclude this theory.It is also unknown why two whole delivery pusher three detachment zones tangled up were returned.Review of the lot history records did not reveal any in-process issue that could account for the observation.No additional complaints against lot number f200200026 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: "the physician was doing a venous embo of a davf where he was coiling off the transverse sinus.His 37th coil was a 9x30 complex standard.The catheter had lots of forward tension and he was packing in a tight spot.He attempted to detach and the coil didn't release after first cycle.He tried a second cycle and xcel was giving christmas tree lights and the coil didn't detach.He tried a third time and pushed the coil and pusher well past the proximal line and it still didn't pop off the pusher.He tried detaching a fourth time.He then tried to remove the coil and it was lodged in the coil mass.He pulled until the coil broke and separted.The coil and pusher stretched as he removed.He then had to remove the catheter and there was coil and pusher stretched out of the sheath.He pulled and broke off more of the coil and pusher.He had to remove the sheath because there was coil and pusher down the sheath.He pulled another segment of coil out until it broke.He placed another sheath and catheter and was able to finish the case without harm to the patient.He used 10 more optimas without any incident.".

• 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: 10778881
• MDR Text Key: 248209605
• Report Number: 3014162263-2020-00036
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00818053026386
• UDI-Public: 00818053026386
• 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: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2022
• Device Model Number: OPTI0930CST10
• Device Catalogue Number: N/A
• Device Lot Number: F200200026
• Date Manufacturer Received: 10/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2020
• 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