MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER XC; BALLOON CATHETER

Model Number	BC0411XC-ID-700-AL
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with this part / lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was stated to be available for return to the manufacturer for evaluation but has not yet been returned.The reported issue could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.The instructions for use (ifu) identifies balloon deflation problem as potential complications associated with use of the device.
Event or Problem Description
As reported, during an m1 aneurysm embolization following subarachnoid hemorrhage, the physician couldn¿t deflate the complaint scepter xc balloon.The devices used were: benchmark, headway 17, synchro standard wire, asahi chikai wire.The complaint scepter xc balloon was prepped under ifu.The contrast and saline ratio in balloon was 60% to 40%, omnipaque 240 was used.The physician is an experience scepter user.After positioning the complaint scepter xc by the side of the m1 aneurysm, he inflated the balloon to test it before he commenced coiling.However, the balloon failed to be deflated.Attempts were made to deflate the balloon with 1,5, and 20ml syringes.The physician had to remove the balloon while it was inflated from m1.The embolization was achieved with another scepter xc balloon and coils.No immediate adverse event happened on patient due to this complaint product.The case was completed with another scepter xc balloon.
Additional Manufacturer Narrative
Physical device evaluation - 10/10/2024: items returned for investigation: scepter xc.Items not returned for investigation: n/a.The device was returned with the balloon deflated and residual blood within the balloon.The hub was intact.The distal section of the device was flattened.The balloon was inflated with dyed saline and successfully deflated during the investigation; however, air purging was unsuccessful due to prior inflation of the balloon.No damage or other anomaly to the air purge channel was observed.Imaging review, p24-5134, mvi, md, 10/9/2024: six radiographic images are supplied.Qper-1832a: ap oblique right ica dsa, subtracted, with contrast, arterial phase.There is a 3-4 mm mid-m1 aneurysm projecting superiorly.The neck appears relatively wide, but it is difficult to tell.A guidewire/scepter xc combination is seen, with the wire in a vertical mid-m2 branch.The balloon is not inflated and the aneurysm is located at the proximal 1/3 between the balloon markers.The distal marker is in the distal m1.A microcatheter/guidewire combination is seen.With the wire in the mid supraclinoid ica and the microcatheter tip just distal to the ophthalmic artery.There is a duplication of the m1, with the superior m1 carrying the aneurysm.Qper-1832b: ap oblique right ica dsa, unsubtracted, with contrast, arterial phase.The scepter balloon is inflated; its wire is off the screen.The microcatheter and wire are at the proximal balloon.Qper-1832c: ap oblique right ica dsa, subtracted, with contrast, arterial phase.The scepter balloon is inflated; its wire is off the screen.The microcatheter and wire are at the proximal balloon.There is no flow beyond the balloon.There is opacification of the inferior duplicated m1.Qper-1832d: ap oblique right ica dsa, subtracted, with contrast, arterial phase.The scepter balloon has been removed.The microcatheter and wire are at the proximal balloon.There is no flow beyond the balloon.The other microcatheter is still in place, with the wire at its tip, but not beyond.The tip of the microcatheter is about 2-3 mm from the m1 aneurysm.The visualized arteries are normal, with no evidence of vasospasm or damage.Qper-1832e: right cervical cca dsa, ap, subtracted, with contrast, arterial phase.Normal cca, ica, and eca.Qper-1832f: right cervical cca dsa, lateral, subtracted, with contrast, arterial phase.Normal cca, ica, and eca.These images do not explain why the scepter balloon did not deflate.Investigation conclusion: six radiographic images were provided for review.The review of the images as follows: qper-1832a: ap oblique right ica dsa, subtracted, with contrast, arterial phase.There is a 3-4 mm mid-m1 aneurysm projecting superiorly.The neck appears relatively wide, but it is difficult to tell.A guidewire/scepter xc combination is seen, with the wire in a vertical mid-m2 branch.The balloon is not inflated and the aneurysm is located at the proximal 1/3 between the balloon markers.The distal marker is in the distal m1.A microcatheter/guidewire combination is seen with the wire in the mid supraclinoid ica and the microcatheter tip just distal to the ophthalmic artery.There is a duplication of the m1, with the superior m1 carrying the aneurysm.Qper-1832b: ap oblique right ica dsa, unsubtracted, with contrast, arterial phase.The scepter balloon is inflated; its wire is off the screen.The microcatheter and wire are at the proximal balloon.Qper-1832c: ap oblique right ica dsa, subtracted, with contrast, arterial phase.The scepter balloon is inflated; its wire is off the screen.The microcatheter and wire are at the proximal balloon.There is no flow beyond the balloon.There is opacification of the inferior duplicated m1.Qper-1832d: ap oblique right ica dsa, subtracted, with contrast, arterial phase.The scepter balloon has been removed.The microcatheter and wire are at the proximal balloon.There is no flow beyond the balloon.The other microcatheter is still in place, with the wire at its tip, but not beyond.The tip of the microcatheter is about 2-3 mm from the m1 aneurysm.The visualized arteries are normal, with no evidence of vasospasm or damage.Qper-1832e: right cervical cca dsa, ap, subtracted, with contrast, arterial phase.Normal cca, ica, and eca.Qper-1832f: right cervical cca dsa, lateral, subtracted, with contrast, arterial phase.Normal cca, ica, and eca.These images do not explain why the scepter balloon did not deflate.The investigation of the returned scepter device found the distal section flattened and residual blood in the balloon; however, the balloon was able to deflate normally during functional testing.Air was observed to partially fill the balloon during the functional testing; however, it is difficult to fully purge the balloon of air once it has already been inflated.No damage or other anomaly to the air purge channel was observed.The physical evaluation of the device could not identify the conditions or circumstances that led to the flattened distal section, but the damage is consistent with the device experiencing forces exceeding the device¿s yield strength and did not impede the balloon¿s ability to deflate during the investigation.
Event or Problem Description
See h11.

• Brand Name: SCEPTER XC
• Common Device Name: BALLOON CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 20328833
• Report Number: 2032493-2024-00724
• Device Sequence Number: 9628222
• Product Code: DQY
• UDI-Device Identifier: 00842429117583
• UDI-Public: (01)00842429117583(11)240423(17)270331(10)0000580978
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BC0411XC-ID-700-AL
• Device Lot Number: 0000580978
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown