MAUDE Adverse Event Report: MERIT MEDICAL MANUFACTURING IMPRESS®.BRAIDED CATHETER; PERIPHERAL CATHETERS

Catalog Number	46538BER
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device will not be returning for evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.
Event or Problem Description
The account alleges that a 60yo male presented with a fall from 2 meters.A pelvic ct study demonstrated a fracture with arterial injuries.Patient was admitted and sent for angiogram.An 18g access needle was advanced into right cfa followed by 5f 10cm introducer sheath.An 0.035" 150cm guidewire and a 5f catheter were used for left iia angiogram procedure.A pseudoaneurysm and av fistula from left superior gluteal artery was noted.Super-selective angiograms of various branches of left superior gluteal artery by using 2.0f microcatheter with 0.016" guidewire.The microcatheter 2.0f was exchanged to a 4f and 1.98f soft catheter due to inadequate coil support.A coil embolization was performed to control bleeding by using 19 coils via 1.98f via the 4f catheter.The catheter tip was advanced to proximal part of left superior gluteal artery.After completing the coil embolization procedure, the 4f catheter was pulled back, about 3 cm, dsa was performed.The 4f catheter tip detached within the patient.A vascular snare was used to attempt removal of the retained catheter, but it kept cutting the foreign body into small pieces.The residual portion of the catheter tip was pushed deeper into the left iia by using 4x40mm pta balloons where they remain.Arterial access route was closed by 6f closure device.Due to thrombocytopenia, [very low platelet blood count].The patient was transferred to recovery ward.The patient improved and was referred to local hospital for a skeletal traction procedure at the left proximal tibia.A follow-up cta was ordered in 2 weeks.The patient has not yet been scheduled for additional interventions at this time.
Additional Manufacturer Narrative
The suspect medical device was not returned for investigation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned later, the investigation will be reopened.

• Brand Name: IMPRESS®.BRAIDED CATHETER
• Common Device Name: PERIPHERAL CATHETERS
• Manufacturer (Section D): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 15336339
• Report Number: 3010665433-2022-00094
• Device Sequence Number: 20442867
• Product Code: DQO
• UDI-Device Identifier: 00884450030134
• UDI-Public: 884450030134
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K053171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2022

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 Catalogue Number: 46538BER
• Device Lot Number: E1919791
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 016, 035 INTERVENTIONAL GUIDEWIRES; 19 CONCERTO COILS; 2.0F YASHIRO MICROCATHETER; PARKWAY SOFT CATHETER
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male