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Model Number PED2-375-20
Device Problems Positioning Failure (1158); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/19/2020
Event Type  malfunction  
Manufacturer Narrative
The pipeline flex (model: ped2-375-20 lot: a763659) and marksman micro catheter (model: fa-55150-1030 lot: 218342883) were returned for analysis. The marksman micro catheter total length was measured to be ~157. 5cm and the usable length was measured to be ~150. 0cm, which is within specification: total (reference)
157cm ± 3cm, usable
150cm ± 3cm. No flash or voids molded were found within the catheter hub. No damages or anomalies were found with the hub, distal tip or marker band. The marksman catheter was found accordioned between ~28. 5cm to ~24. 0cm and between ~10. 2cm to ~3. 5cm from the distal end. The micro catheter was flushed with water and water exited very slowly out from the catheter tip. The pipeline flex distal wire and distal braid were found partially deployed out of the distal end of the catheter. The pipeline flex pusher was retracted out of the marksman micro catheter. The distal wire and braid remained in the distal portion of the micro catheter. Resistance was found when retracting distal braid and micro catheter out of the tip of the micro catheter. The location of the separation was proximal to the wire weld. The inner diameter of the marksman was measured to be 0. 0265¿ for both the ends which is within specification (0. 027¿ ± 0. 001¿) and compatible for use with the pipeline flex. The catheter was then tested by running an in-house 0. 0260¿ mandrel through microcatheter. The mandrel passed through the catheter hub, catheter body and distal tip with light resistance encountered near the distal end. No damages or irregularities were found with the proximal pusher. The hypotube was found intact and unstretched. The distal wire was found separated from the hypotube proximal to the wire weld. The distal pad restraint and the re-sheathing pad were found loose on the distal wire. The tip coil was found damaged. No other damages or irregularities were found with the distal wire, dps sleeves or sleeve restraints. Once pushed out from within the catheter, both ends of the braid were found to be fully opened. The proximal end was found undamaged. The distal end was found damaged and frayed. No other anomalies were observed. Based on the analysis findings, the customer report of ¿difficult placement/positioning¿ could not be confirmed. These sorts of complaints usually cannot be confirmed during device analysis and the customer did not submit any images for review. Possible causes for failure are patient vessel tortuosity, braid incorrectly sized to the vessel, resistance, other indwelling endovascular stents, braid damaged, braid deployed in vessel bend, microcatheter tip not correctly placed or braid not anchored correctly. Customer reported the vessel tortuosity as normal. The customer report of ¿catheter resistance¿ and ¿resistance during retrieval¿ was confirmed as the braid and distal wire was found stuck within the distal end of the micro catheter. In addition, light resistance was found with the in-house mandrel near the accordioned section. From the damages found on the coil tip (damaged), distal pad restraint (separate), separated distal wire, braid (damaged), micro catheter (accordioned); it appears high force was used, or resistance was encountered. The distal wire of the pipeline flex delivery system was possibly detached due to the solder tensile failure when attempting to retract the pipeline flex w/ shield against resistance. A review of the manufacturing process did not uncover any deficiencies with regard to the soldering process. Proper soldering technique and surface preparation (tinning) were well defined and documented appropriately in the associated manufacturing procedures. In addition, the elemental analysis conducted through scanning electron micrographic (sem) / energy dispersive spectroscopy (eds) showed presence of soldering material (tin); thereby indicating that the soldering was conducted. The proof load of 2. 5n performed on 100% of the devices (section starting with hypotube solder to distal pad solder joint). There was no non-conformance to specification that lead to the detachment issues. Furthermore, the review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection. Per our instructions for use (ifu): "discontinue delivery of the device if high force or excessive friction is encountered. Identify the cause of the resistance and remove device and microcatheter simultaneously. Advancement of the ped against resistance may result in device damage or patient injury. Never advance or withdraw an intralumenal device against resistance until the cause of resistance is determined by fluoroscopy. If the cause cannot be determined, withdraw the catheter. Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel. Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis. ¿ if information is provided in the future, a supplemental report will be issued.
Event Description
Medtronic received a report that the pipeline experienced resistance in the middle of the marksman catheter. It was reported that in the m1 segment, after 7-8 mm were released it was observed that there was not correct apposition of the device. It was extremely difficult to reposition, and resistance was noted in the catheter during release in the supraclinoid portion of the ophthalmic segment. After several repositioning attempts, the pipeline was withdrawn. The patient did not experience any injury or complications. The devices were prepared according to the instructions for use (ifu). The patient was undergoing treatment for a saccular, unruptured aneurysm located in the left carotid ophthalmic artery. The max diameter was 4. 5 mm. The neck diameter was 3 mm. The landing zone was 6 mm distal, and 5 mm proximal. The patient¿s vessel tortuosity was normal. Ancillary devices include a marksman microcatheter. Additional information was received reporting that the pipeline generated resistance throughout the catheter. It was noted that the catheter staying in place during deployment of the pipeline.
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Manufacturer (Section D)
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
MDR Report Key11008882
MDR Text Key225567092
Report Number2029214-2020-01303
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-375-20
Device Catalogue NumberPED2-375-20
Device Lot NumberA763659
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/09/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial