MAUDE Adverse Event Report: PERFUZE LTD MILLIPEDE 088 ACCESS CATHETER; PERCUTANEOUS CATHETER

Catalog Number	PMA088121US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thromboembolism (2654)
Date of Event	07/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices were discarded after use and therefore not available for return and investigation.There were no device malfunctions noted for the millipede 088 or millipede 070 catheters.Based on the information provided, the exact cause of the events is unknown.The relationship of the millipede catheters to the events could not be established.It is unclear if the events were caused by the millipede catheters, the third-party guidewire or the third-party microcatheter.The manufacturing records for the millipede catheters were reviewed and demonstrated that the product met all the design and manufacturing specifications.The following mfr # were submitted: mfr # 3015701715-2024-00003 for millipede 070,.
Event or Problem Description
A patient with a nihss score of 17 and baseline mtici score of 0 was treated for a left middle cerebral artery occlusion.A third party 8f sheath was used for access.The millipede 088 catheter was navigated over a millipede 070 catheter.The millipede catheters were navigated over a third party microcatheter and guidewire.It was recorded that the clot was crossed with the third party microcatheter and guidewire during each pass.After 3 passes, it was noted that there was embolization of clot to the left anterior cerebral artery.A third party stentriever was used in combination with aspiration for two subsequent passes, but the embolus could not be retrieved.The final mtici score at the end of the procedure was 2b.Following the procedure, the patient rapidly deteriorated and the patient's family declined further continuance of care.The patient died 5 days after the procedure.The treating physician attributed the death to the severity of the stroke and the patient's age.According to the physician, the stroke was rapidly evolving to a larger ischemic stroke which led to early neurological deterioration despite arterial recanalization.

• Brand Name: MILLIPEDE 088 ACCESS CATHETER
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): PERFUZE LTD; unit 6 galway business park; dangan; galway, galway H91W7 CP; EI H91W7CP
• Manufacturer (Section G): PERFUZE LTD; unit 6 galway business park; dangan; galway, galway H91 W 7CP; EI H91 W7CP
• Manufacturer Contact: jeanine o'donnell ; unit 6 galway business park; dangan; galway, galway H91 W-7CP ; EI H91 W7CP
• MDR Report Key: 20851300
• Report Number: 3015701715-2024-00004
• Device Sequence Number: 14435216
• Product Code: QJP
• UDI-Device Identifier: 05391539370142
• UDI-Public: (01)05391539370142(10)DHR143(17)250510
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K233648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/10/2025
• Device Catalogue Number: PMA088121US
• Device Lot Number: DHR143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 027 HEADWAY MICROCATHETER (MICROVENTION); 8F SUPER ARROW-FLEX SHEATH (TELEFLEX); ASPIRATION PUMP (PENUMBRA); CHIKAI 18 GUIDEWIRE (ASAHI); EMBOTRAP 5MM X 37MM (CERENOVOUS); MILLIPEDE 070 ASPIRATION CATHETER (PERFUZE)
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 57 KG