MAUDE Adverse Event Report: UNKNOWN SET ASPIREX S 6F 135CM; THROMBECTOMY & ATHERECTOMY

Model Number	80325
Medical Device Problem Codes	Overheating of Device (1437); Mechanical Jam (2983)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/13/2022
Type of Reportable Event	Death
Event or Problem Description
It was reported that during a recanalization procedure, the catheter and guidewire allegedly jammed and overheated.It was later reported that while transporting the patient to the post operation area, the patient¿s bp dropped and crashed.The patient reportedly expired.
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation of the reported event is currently underway.The medical device manufacturer and manufacturing location for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.Expiry date: 08/2024.
Additional Manufacturer Narrative
H10: the medical device manufacturer (d3) and manufacturing location (g1) for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical sample was returned for evaluation.Much blood was visible in the shield housing and few blood was in the collecting bag.Also, guide wire looked like not used with no sign of usage and the coating was totally fine.There were no deformation, abbreviation, blood and other materials visible.A catheter was physically investigated.The catheter showed a high amount of blood.The catheter doesn¿t show any damage, kinks and breaks.The catheter was rotated with magnet, without flushing before.The guide wire could not go through, 8cm from the tip and the guidewire was removed and tried again.It was possible to get the guide wire through the whole length of the catheter.After flushing full aspiration capacity could be reestablished.No malfunction was detected.The investigation is unconfirmed for the reported issues.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: b5, d4 (expiry date: 08/2024), g3.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : see h10.
Event or Problem Description
It was reported that during a recanalization procedure in the iliofemoral vein, accessing from the ankle, the catheter and guidewire allegedly jammed and overheated.It was later reported that while transporting the patient to the post operation area, the patient¿s bp dropped and crashed.The patient reportedly expired.

• Brand Name: SET ASPIREX S 6F 135CM
• Common Device Name: THROMBECTOMY & ATHERECTOMY
• Manufacturer (Section D): UNKNOWN; BR
• Manufacturer (Section G): UNKNOWN; BR
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15591663
• Report Number: 3008439199-2022-00148
• Device Sequence Number: 2314761
• Product Code: DQX
• UDI-Device Identifier: 07640142811329
• UDI-Public: (01)07640142811329
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K220270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 80325
• Device Catalogue Number: 80325
• Device Lot Number: 220994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2022
• 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: Death
• Patient Age: 52 YR
• Patient Sex: Female