MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CATHERA; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Model Number	FG15150-0615-1S
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis : as found condition: the phenom-27 catheter was returned within as shipping box; within a sealed plastic bio-pouch; and within an opened phenom-27 inner pouch.Visual inspection/damage location details: the total and usable lengths of the catheter were measured to be within specifications.Upon visual inspection, no damages or irregularities were found with the phenom 27 catheter hub.The phenom 27 catheter body was found to be broken in three segments.In addition, the catheter distal tip was appeared to be flattened.No other anomalies were observed.Testing/analysis: the phenom 27 catheter was flushed, water exited from the distal tip.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter flattened/damage¿ was confirmed and the root cause could not be determined.From the damages seen on the catheter body; it appears there was high force used.It is likely these damages occurred when the customer attempted to advance and retrieve the pipeline through the phenom catheter against resistance.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the end of the catheter was flat.The patient was undergoing surgery for aneurysm pipeline blood flow guided therapy.The access vessel was the femoral artery with a diameter of 5mm.It was noted the patient's vessel tortuosity was normal.It was reported that the stent could not be pushed in the catheter.After the whole was withdrawn, it was found that the distal end of the catheter was flat, the lumen was deformed.No patient symptoms or further complications were reported as a result of this event.The reported device and any accessory devices were prepared and the catheter was flushed as indicated in the ifu.

• Brand Name: CATHERA
• Common Device Name: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13715996
• Report Number: 2029214-2022-00380
• Device Sequence Number: 17709178
• Product Code: BSY
• UDI-Device Identifier: 00847536041868
• UDI-Public: 00847536041868
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2022

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 Expiration Date: 06/30/2024
• Device Model Number: FG15150-0615-1S
• Device Catalogue Number: FG15150-0615-1S
• Device Lot Number: JU21-072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2021
• 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
• Patient Age: 73 YR
• Patient Sex: Female