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

Model Number	FG15150-0630-1S
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: ¿ as found condition: the pipeline flex shield embolization device and proximal segment of phenom 27 catheter were returned for analysis within a shipping box; and within a plastic bio-pouch.The pipeline flex shield device was returned outside the phenom 27 catheter.¿ damage location details: the phenom 27 catheter body was found to be cut and only proximal segment was returned for analysis.No damage was found with proximal section of phenom 27 catheter.No flash or voids molded were observed in the hub.No damage was found with hub.No other anomalies were observed.¿ testing/analysis: the total length of proximal segment is ~14.8cm.The proximal segment of catheter was flushed with water and water exited out from distal end.The broken end of pushwire was sent out for sem (scanning electron microscopy) analysis.¿ conclusion: based on the device analysis and reported information, the customer¿s report of ¿stuck in catheter hub¿ was confirmed.The pipeline flex shield braid was found within catheter hub.However, the root cause could not be determined.The pipeline flex shield pushwire was found damaged and broken and the phenom catheter was found cut.From the damages seen on the catheter body (cutting), pipeline flex shield pushwire(broken), pipeline flex shield braid (fraying) and hypotube (stretching); it is likely high force used during the delivery.Additionally, the pushwire was found to be separated proximal to the dps sleeves.Per the sem result the wire failed via torsional overload.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.There was no non-conformance to specifications identified that led to the reported issue.Event related to regualtory report: 2029214-2022-02152.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Event or Problem Description
2022-oct-24 mpxr 996323 (rep, hcp, for, dis): medtronic received report that the pipeline jammed in the hub of the phenom 27 microcatheter.It was noted that the devices were prepared as indicated in the instructions for use (ifu).The tip of the sheath was seated securely in the catheter hub.The catheter was flushed per ifu.Both devices were replaced with another manufacturer's products to complete the procedure.There was no noted patient involvement.2022-11-08 e1 (for, rep, hcp): new information was received.There was no damage observed on the pipeline or catheter.

• 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: 16015412
• Report Number: 2029214-2022-02153
• Device Sequence Number: 6503083
• Product Code: BSY
• UDI-Device Identifier: 00847536041875
• UDI-Public: 00847536041875
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/20/2022

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: 11/30/2024
• Device Model Number: FG15150-0630-1S
• Device Catalogue Number: FG15150-0630-1S
• Device Lot Number: DE21-007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2022
• Initial Report FDA Received Date: 12/20/2022
• Date Device Manufactured: 12/03/2021
• 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 Sex: Unknown